Skip to Content

Notice

Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing

This document has a comment period that ends in 47 days. (03/09/2020) Submit a formal comment

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

DATES:

The ANDA holders may submit a request for a hearing by February 10, 2020. Submit all data, information, and analyses upon which the request for a hearing relies by March 9, 2020. Submit electronic or written comments by March 9, 2020.

ADDRESSES:

The request for a hearing may be submitted by the ANDA holders by either of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments to submit your request for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a hearing, will be posted to the docket unchanged.

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such Start Printed Page 1161as a manufacturing process. The request for a hearing must include the Docket No. FDA-2019-N-5254 for “Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.” The request for a hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

The ANDA holders may submit all data and analyses upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:

  • Confidential Submissions—To submit any data analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analyses. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov or available at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Submit both copies to the Dockets Management Staff. Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law.

Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties, submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-5254 for “Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-7920, Martha.Nguyen@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The holders of approved ANDAs to market new drugs for human use are required to submit annual reports to FDA concerning each of their approved ANDAs under §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). The holders of the approved ANDAs listed in the following table have repeatedly failed to submit the required annual reports and have not responded to the Agency's request, sent by certified mail, for submission of the reports.

Application No.DrugApplicant
ANDA 020374Inpersol-LC/LM With Dextrose 1.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 milligrams (mg)/100 milliliters (mL); 1.5 grams (g)/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mLFresenius USA, Inc., 2637 Shadelands Dr., Walnut Creek, CA 94598.
Start Printed Page 1162
Inpersol-LC/LM With Dextrose 2.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL
Inpersol-LC/LM With Dextrose 3.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 3.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL
Inpersol-LC/LM With Dextrose 4.25% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL
ANDA 040057Epinephrine and Lidocaine Hydrochloride (HCl) Injection, 0.01 mg/mL; 2% and 0.02 mg/mL; 2%Eastman Kodak Co., 343 State St., Rochester, NY 14650.
ANDA 040168Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2%Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 West Main St., Morton Grove, IL 60053.
ANDA 040192Prednisolone Syrup, 15 mg/5 mLWE Pharmaceuticals, Inc., 1142 D St., P.O. Box 1142, Ramona, CA 92065.
ANDA 060074Penicillin G Potassium for Injection, 20,000,000 units/vialPfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
ANDA 060131Tetracycline HCl CapsulesLeiner Health Products, Inc., 901 East 233rd St., Carson, CA 90745.
ANDA 060461Neomycin Sulfate Ointment; Neomycin Sulfate and Hydrocortisone Acetate OintmentAmbix Laboratories, Division of Organics Corp. of America, 210 Orchard St., East Rutherford, NJ 07073.
ANDA 060521Humatin (paromomycin sulfate) Capsules USP, Equivalent to (EQ) 250 mg baseParkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620.
ANDA 060602Penicillin G Potassium PowderJohn D. Copanos and Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225.
ANDA 060627Tribiotic (polymyxin B sulfate, bacitracin, and neomycin sulfate) Ointment, 5000 units/400 units/5 mgAmbix Laboratories, Division of Organics Corp. of America.
ANDA 060709Oleandomycin InjectionRoerig, Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
ANDA 060724Pyocidin-HC (neomycin sulfate, polymyxin B sulfate, and hydrocortisone) Otic SolutionKasco-EFCO Laboratories, Inc., Cantiague Rock Rd., Hicksville, NY 11802.
ANDA 060769Tetracycline SyrupWest-Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ 07724.
ANDA 060773Tetracycline SyrupLeiner Health Products, Inc.
ANDA 060870Oxytetracycline InjectionProter S.p.A., c/o Richmar International, Inc., 1706 Birch Rd., McLean, VA 22101.
ANDA 061034Lincomycin HCl PowderPharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001.
ANDA 061064Nystatin OintmentLederle Laboratories, Division of American Cyanamid Co., 401 North Middletown Rd., Pearl River, NY 10965.
ANDA 061087Benzocaine, Oxytetracycline HCl, and Polymyxin B Sulfate Otic SolutionPfizer Laboratories, Division of Pfizer, Inc.
ANDA 061154Hydrocortisone Acetate and Neomycin Sulfate OintmentAmbix Laboratories, Division of Organics Corp. of America.
ANDA 061209Bacitracin Ointment USP, 500 units/g  Do.
ANDA 061228Griseofulvin CapsulesOwen Laboratories, Division of Alcon Laboratories, 3737 Beltline Rd., Dallas, TX 75234.
ANDA 061483Penicillin G Potassium TabletsLeiner Health Products, Inc.
ANDA 061518Bacitracin Zinc OintmentRexall Drug Co., 135 Chesterfield Industrial Blvd., Chesterfield, MO 63017.
ANDA 061519Bacitracin Zinc and Neomycin Sulfate Ointment  Do.
ANDA 061520Bacitracin Zinc and Neomycin Sulfate/Polymyxin B Sulfate Ointment  Do.
ANDA 061521Bacitracin Zinc, Benzocaine, and Neomycin Sulfate/Polymyxin B Sulfate Ointment  Do.
ANDA 061528Penicillin V Potassium Tablets USP, EQ 250 mg base and EQ 500 mg baseAmerican Antibiotics, Inc., 6110 Robinwood Rd., Baltimore, MD 21225.
ANDA 061529Penicillin V Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL  Do.
ANDA 061532Ampicillin Trihydrate CapsulesLeiner Health Products, Inc.
ANDA 061601Ampicillin for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mLAmerican Antibiotics, Inc.
ANDA 061602Ampicillin Capsules USP, EQ 250 mg base and EQ 500 mg base  Do.
ANDA 061632Ampicillin Trihydrate Capsules, 250 mgChromalloy Pharmaceuticals, Inc., 5353 Grosvenor Blvd., Los Angeles, CA 90066.
ANDA 061652Oxytetracycline CapsulesWarner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950.
ANDA 061674Penicillin V Potassium TabletsLeiner Health Products, Inc.
Start Printed Page 1163
ANDA 061697Griseofulvin CapsulesWatson Laboratories, Inc., 311 Bonnie Cir., Corona, CA 92880.
ANDA 061699Bacitracin Powder for Rx Compounding, 5,000,000 units/bottleApothekernes Laboratorium A.S., c/o AL Laboratories, Inc., 1 Executive Dr., Fort Lee, NJ 07024.
ANDA 061701Tetracycline Syrup, 125 mg/5 mLAH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220.
ANDA 061725Cyclopar (tetracycline HCl) Capsules USP, 250 mg and 500 mgWarner-Lambert Co.
ANDA 061833Oxytetracycline HCl Capsules, 250 mgPliva, c/o Transtrade USA, Ltd., 515 Madison Ave., 4th Floor East, New York, NY 10022.
ANDA 061847Bleomycin Sulfate InjectionTakasaki Plant, Nippon Kayaku Co., Ltd., 500 5th Ave., Suite 1726, New York, NY 10110.
ANDA 061857Penicillamine PowderChemiewerk Homberg, c/o Wallace Laboratories, Cranbury, NJ 08512.
ANDA 061903Bacitracin Zinc and Polymyxin B Sulfate OintmentAmbix Laboratories, Division of Organics Corp. of America.
ANDA 061943Chloramphenicol Ophthalmic Solution, 0.5%Lederle Laboratories, Division of American Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470.
ANDA 062032Erythromycin Stearate Tablets, EQ 250 mg base and EQ 500 mg baseWarner-Lambert Co.
ANDA 062085Tetracycline HCl Capsules, 250 mgMM Mast and Co., 4152 Ruple Rd., Cleveland, OH 44121.
ANDA 062175Tetracycline HCl Capsules, 250 mgWarner-Lambert Co.
ANDA 062205Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg baseCeph International Corp. c/o Mova Pharmaceutical Corp., State Rd #1 Jose Garrido St., Cagus, PR 00725.
ANDA 062215Oxytetracycline HCl CapsulesLederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215.
ANDA 062340Gentamicin Sulfate InjectionPharmaceutical Specialist Association, 9852 Cowden St., Philadelphia, PA 19115.
ANDA 062467E-Solve 2 (erythromycin) Lotion, 2%Syosset Laboratories, Inc., 150 Eileen Way, Syosset, NY 11791.
ANDA 062758Eryzole (erythromycin ethylsuccinate and sulfisoxazole acetyl) Granules, EQ 200 mg base/5 mL; EQ 600 mg base/5 mLAlra Laboratories, Inc., 3850 Clearview Ct., Gurnee, IL 60031.
ANDA 062869Cephalexin Capsules USP, EQ 500 mg baseJerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716.
ANDA 062870Cephalexin Capsules USP, EQ 250 mg base  Do.
ANDA 062944Clindamycin Phosphate Topical Solution USP, EQ 1% baseBOCA Pharmacal, LLC., 3550 North West 126th Ave., Coral Springs, FL 33065.
ANDA 070104Chlorhexidine Gluconate Topical Solution, 4%Matrix Medical Corp., 1825 South 3730 West, Salt Lake City, UT 84104.
ANDA 071054Constilac (lactulose) Solution, 10 g/15 mLAlra Laboratories, Inc.
ANDA 071057Ibu-tab 200 (ibuprofen) Tablets, 200 mg  Do.
ANDA 071058Ibu-tab (ibuprofen) Tablets, 400 mg  Do.
ANDA 071059Ibu-tab (ibuprofen) Tablets, 600 mg  Do.
ANDA 071104Leucovorin Calcium Tablets, EQ 15 mg baseXanodyne Pharmacal, Inc., 7310 Turfway Rd., Suite 490, Florence, KY 41042.
ANDA 071139Trazodone HCl Tablets, 50 mgAmerican Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716.
ANDA 071140Trazodone HCl Tablets, 100 mg  Do.
ANDA 071331Cholac (lactulose) Solution, 10 g/15 mLAlra Laboratories, Inc.
ANDA 071362Meclofenamate Sodium Capsules USP, 50 mgAmerican Therapeutics, Inc.
ANDA 071363Meclofenamate Sodium Capsules USP, 100 mg  Do.
ANDA 071419Brian Care (chlorhexidine gluconate) Topical Solution, 4%Soapco, Inc., P.O. Box 5490, Pleasanton, CA 94566.
ANDA 071429Clorazepate Dipotassium Capsules, 3.75 mgAmerican Therapeutics, Inc.
ANDA 071430Clorazepate Dipotassium Capsules, 7.5 mg  Do.
ANDA 071431Clorazepate Dipotassium Capsules, 15 mg  Do.
ANDA 071569Danazol Capsules USP, 200 mg  Do.
ANDA 071787Gen-Xene (clorazepate dipotassium) Tablets, 3.75 mgAlra Laboratories, Inc.
ANDA 071788Gen-Xene (clorazepate dipotassium) Tablets, 7.5 mg  Do.
ANDA 071789Gen-Xene (clorazepate dipotassium) Tablets, 15 mg  Do.
ANDA 071955Oxazepam Capsules USP, 10 mgAmerican Therapeutics, Inc.
ANDA 071956Oxazepam Capsules USP, 15 mg  Do.
ANDA 071957Oxazepam Capsules USP, 30 mg  Do.
ANDA 071962Leucovorin Calcium Tablets, EQ 10 mg baseXanodyne Pharmacal, Inc.
ANDA 071965Ibu-tab (ibuprofen) Tablets, 800 mgAlra Laboratories, Inc.
ANDA 072022Triamterene and Hydrochlorothiazide Tablets, 75 mg/50 mgAmerican Therapeutics, Inc.
ANDA 072129Maprotiline HCl Tablets USP, 25 mg  Do.
ANDA 072130Maprotiline HCl Tablets USP, 50 mg  Do.
ANDA 072131Maprotiline HCl Tablets USP, 75 mg  Do.
ANDA 072190Metaproterenol Sulfate Inhalation Solution, 5%Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 072196Milophene (clomiphene citrate) Tablets, 50 mgMilex Products, Inc., 5915 Northwest Highway, Chicago, IL 60631.
ANDA 072255Microderm (chlorhexidine gluconate) Topical Solution, 4%Johnson and Johnson Medical, Inc., 2500 Arbrook Blvd., Arlington, TX 76014.
Start Printed Page 1164
ANDA 072292Prevacare R (chlorhexidine gluconate) Topical Solution, 0.5%  Do.
ANDA 072295Microderm (chlorhexidine gluconate) Topical Sponge, 4%  Do.
ANDA 072307Fenoprofen Calcium Capsules USP, 200 mgAmerican Therapeutics, Inc.
ANDA 072308Fenoprofen Calcium Capsules USP, 300 mg  Do.
ANDA 072309Fenoprofen Calcium Tablets USP, 600 mg  Do.
ANDA 072782Prazosin HCl Capsules USP, 1 mg  Do.
ANDA 072783Prazosin HCl Capsules USP, 2 mg  Do.
ANDA 072784Prazosin HCl Capsules USP, 5 mg  Do.
ANDA 073416E-Z Scrub (chlorhexidine gluconate) Topical Sponge, 4%Becton Dickinson Surgical System, 9450 South State St., Sandy, UT 84070.
ANDA 073535Piroxicam Capsules, 10 mgMutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 074523Metromidol (metronidazole) Tablets, 250 mg and 500 mgLaboratorios Applicaciones Farmaceuticas S.A. de CV, c/o Richard Hamer Association, Inc., P.O. Box 16598, Fort Worth, TX 76162.
ANDA 074560Flurbiprofen Tablets USP, 100 mgTheragen, Inc., 10 Lake Dr., East Windsor, NJ 08520.
ANDA 074702Metaproterenol Sulfate Syrup, 10 mg/5 mLWockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 074881Iopamidol Injection, 41%, 51%, 61%, and 76%Cook Imaging Corp., 927 South Curry Pike, P.O. Box 3068, Bloomington, IN 47403.
ANDA 074988Aspirin, Caffeine, and Orphenadrine Citrate Tablets, 385 mg/30 mg/25 mg and 770 mg/60 mg/50 mgJerome Stevens Pharmaceuticals, Inc.
ANDA 075181Prednisolone Sodium Phosphate Oral Solution, EQ 5 mg base/5 mLWE Pharmaceuticals, Inc.
ANDA 075260Tretinoin Topical Solution, 0.05%Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 075414Nifedipine Extended-Release Tablets, 90 mgMartec USA, LLC, 1800 North Topping Ave., Kansas City, MO 64120.
ANDA 075507Ipratropium Bromide Inhalation Solution, 0.02%Pharmascience, Inc., 10 Orchard Pl., Tenafly City, NJ 07670.
ANDA 075569Thallous Chloride TL 201 Injection USP, 1 millicurie (mCi)/mLTrace Life Sciences, Inc., 2101 Shady Oaks, Denton, TX 76205.
ANDA 075586Metaproterenol Sulfate Inhalation Solution, 0.4% and 0.6%Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 075619Minoxidil Extra Strength (for Men) Topical Solution, 5%Avacor Products, LLC, 227 East 56th St., 3rd Floor, New York, NY 10022.
ANDA 075766Calcitriol Injection, 1 microgram (mcg)/mL and 2 mcg/mLFresenius Medical Care North America, 95 Hayden Ave., Lexington, MA 02421.
ANDA 075941Strontium Chloride SR-89 Injection, 1 mCi/mLBio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103.
ANDA 077072Ipratropium Bromide Inhalation Solution, 0.02%Landela Pharmaceutical, 776 East Riverside Dr., Suite 150, Eagle, ID 83616.
ANDA 077218ThyroShield (potassium iodide) Oral Solution USP, 65 mg/mLArco Pharmaceuticals, LLC, 7605 Maryland Ave., St. Louis, MO 63105.
ANDA 077569Albuterol Sulfate Inhalation Solution, EQ 0.083% baseLandela Pharmaceutical.
ANDA 080024Sulfacel-15 (sulfacetamide sodium) Ophthalmic Solution, 15%Optopics Laboratories Corp., P.O. Box 210, Fairton, NJ 08320.
ANDA 080036Sosol (sulfisoxazole) Tablets, 500 mgMK Laboratories, Inc., 424 Grasmere Ave., Fairfield, CT 06430.
ANDA 080366Soxazole (sulfisoxazole) Tablets, 500 mgAlra Laboratories, Inc.
ANDA 080380Bamate (meprobamate) Tablets, 200 mg and 400 mg  Do.
ANDA 080483Hi-cor (hydrocortisone) Cream, 2.5%C and M Pharmacal, Inc., 1519 East 8 Mile Rd., Hazel Park, MI 48030.
ANDA 080492Reserpine Tablets, 0.1 mg and 0.25 mgMarshall Pharmacal Corp., 89 Michael St., South Hackensack, NJ 07606.
ANDA 080518Dimenhydrinate Tablets, 50 mgAlra Laboratories, Inc.
ANDA 080519Diphenhydramine HCl Capsules, 25 mg and 50 mg  Do.
ANDA 080525Reserpine Tablets, 0.1 mg and 0.25 mgMK Laboratories, Inc.
ANDA 080592Diphenhydramine HCl Capsules, 50 mgValeant Pharmaceuticals International, One Enterprise, Aliso Viejo, CA 92656.
ANDA 080660Ocusulf (sulfacetamide sodium) Ophthalmic Solution, 10% and 30%Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories, 40 Main St., P.O. Box 210, Fairton, NJ 08320.
ANDA 080714Diphenhydramine HCl Oral Solution, 12.5 mg/5 mLAlra Laboratories, Inc.
ANDA 080715Dimenhydrinate Oral Solution, 12.5 mg/4 mL  Do.
ANDA 080941Isoniazid Tablets, 100 mgMK Laboratories, Inc.
ANDA 080970Methscopolamine Bromide Tablets, 2.5 mgPrivate Formulations, Inc., 460 Plainfield Ave., Edison, NJ 08818.
ANDA 081145Aspirin and Methocarbamol Tablets, 325 mg/400 mgJerome Stevens Pharmaceuticals, Inc.
ANDA 083001Triamcinolone Acetonide Aerosol Foam EmulsionLederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215.
ANDA 083087Diphenhydramine HCl Capsules, 25 mg and 50 mgMK Laboratories, Inc.
ANDA 083088Diphenhydramine HCl Elixir, 12.5 mg/5 mL  Do.
ANDA 083264Pentobarbital Sodium Capsules, 100 mgValeant Pharmaceuticals International.
Start Printed Page 1165
ANDA 083286Chlorpheniramine Maleate TabletsMarshall Pharmacal Corp.
ANDA 083315Procaine HCl Injection, 1% and 2%Elkins Sinn Pharmaceutical Co., c/o ESI Lederle, 2 Esterbrook Ln., Cherry Hill, NJ 08003.
ANDA 083320Acetazolamide Tablets, 250 mgAlra Laboratories, Inc.
ANDA 083389Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 1%Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.
ANDA 083390Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 2%  Do.
ANDA 083457Vitamin A Palmitate Capsules, EQ 25,000 units base and EQ 50,000 units baseMK Laboratories, Inc.
ANDA 083524Butabarbital Sodium Tablets, 16.2 mgMarshall Pharmacal Corp.
ANDA 083525Niacin Tablets, 500 mgMK Laboratories, Inc.
ANDA 083526Folic Acid Tablets, 1 mg  Do.
ANDA 083658Promethazine HCl Tablets, 25 mgPrivate Formulations, Inc.
ANDA 083806Dexamethasone Tablets, 0.75 mgPhoenix Laboratories, Inc., 175 Lauman Ln., East Hicksville, NY 11801.
ANDA 083827Pramine (imipramine HCl) Tablets, 10 mg, 25 mg, and 50 mgAlra Laboratories, Inc.
ANDA 083858Butabarbital Sodium Tablets, 32.4 mgMarshall Pharmacal Corp.
ANDA 083863Sulfisoxazole CreamHolland Rantos Co., Inc., P.O. Box 385, Piscataway, NJ 08854.
ANDA 084185Bethanechol Chloride Tablets, 10 mgWendt Laboratories, Inc., 200 West Beaver, P.O. Box 128, Belle Plaine, MN 56011.
ANDA 084186Bethanechol Chloride Tablets, 25 mg  Do.
ANDA 084188Myotonachol (bethanechol chloride) Tablets, 5 mg, 10 mg, and 25 mgGlenwood, Inc., 83 North Summit St., P.O. Box 518, Tenafly, NJ 07670.
ANDA 084246Cortisone Acetate Tablets, 25 mgEverylife, 2021 15th Ave., West Seattle, WA 98119.
ANDA 084439Prednisolone Tablets, 1 mg, 2.5 mg, and 5 mg  Do.
ANDA 084440Prednisone Tablets, 1 mg, 2.5 mg, and 5 mg  Do.
ANDA 084494Hydrochlorothiazide TabletsWest-Ward Pharmaceutical Corp.
ANDA 084590Pentobarbital Sodium Capsules, 100 mgAnabolic, Inc., 1835 East Cheyenne Rd., Colorado Springs, CO 80905.
ANDA 084631Quinidine Sulfate Tablets USP, 200 mgSandoz, Inc., 4700 Eon Dr., Wilson, NC 27893.
ANDA 084687Niacin Tablets, 500 mgZzeon Pharmaceuticals, Ltd., Jamboree at Kevin, Irvine, CA 92705,
ANDA 084714Hydro-Reserp (hydrochlorothiazide and reserpine) Tablets, 50 mg/0.125 mgABC Holding Corp., P.O. Box 307, 70945 Van Dyke Ave., Romeo, MI 48065.
ANDA 084729Lidocaton (epinephrine and lidocaine HCl) Injection, 0.01 mg/mL and 2%Pharmaton, Ltd., c/o Bass Ullmna and Lustigman, 747 3rd Ave., New York, NY 10017.
ANDA 084803Chlorpromazine HCl Tablets, 10 mgLederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215.
ANDA 084872Meclizine HCl Tablets, 25 mgCM Bundy Co., 2055 Reading Rd., Cincinnati, OH 45205.
ANDA 084902Promethacon (promethazine HCl) Suppository, 50 mgPolymedica Industries, Inc., 2 Constitution Way, Woburn, MA 01801.
ANDA 084931Methamphetamine HCl Tablets, 5 mg and 10 mgRexar Pharmacal, 396 Rockaway Ave., Valley Stream, NY 11581.
ANDA 084933Diethylstilbestrol Tablets, 1 mgWest-Ward Pharmaceutical Corp.
ANDA 084977Halothane Inhalation, 99.99%BH Chemicals, Inc., 500 5th Ave., New York, NY 10036.
ANDA 085009Lygen (chlordiazepoxide HCl) Capsules, 10 mgAlra Laboratories, Inc.
ANDA 085039Folic Acid Tablets USP, 1 mgWendt Laboratories, Inc.
ANDA 085040Isoniazid Tablets USP, 100 mg  Do.
ANDA 085041Meclizine HCl Tablets, 25 mg  Do.
ANDA 085042Methocarbamol Tablets USP, 500 mg  Do.
ANDA 085044Reserpine Tablets USP, 0.25 mg  Do.
ANDA 085075Aerolate III (theophylline) Extended-Release Capsules, 65 mgFleming and Co. Pharmaceuticals, Inc., 1600 Fenton Park Dr., Fenton, MO 63026.
Aerolate JR (theophylline) Extended-Release Capsules, 130 mg.
Aerolate SR (theophylline) Extended-Release Capsules, 260 mg.
ANDA 085107Lygen (chlordiazepoxide HCl) Capsules, 5 mgAlra Laboratories, Inc.
ANDA 085108Lygen (chlordiazepoxide HCl) Capsules, 25 mg  Do.
ANDA 085125Methyltestosterone Sublingual Tablets, 10 mgTablicaps, Inc., P.O. Box 5555, Franklinville, NJ 08322.
ANDA 085217Acetaminophen and Codeine Phosphate Tablets, 325 mg/30 mgEverylife.
ANDA 085235Chlordiazepoxide HCl CapsulesAbbott Laboratories, Pharmaceutical Products Division, 100 Abbott Park Rd., Abbott Park, IL 60064.
ANDA 085236Chlordiazepoxide HCl Capsules  Do.
ANDA 085252Meclizine HCl Tablets, 25 mgABC Holding Corp.
ANDA 085253Meclizine HCl Tablets, 12.5 mg  Do.
ANDA 085282Hydrocortisone Lotion, 0.5% and 1%Mericon Industries, Inc., 8819 North Pioneer Rd., Peoria, IL 61615.
ANDA 085383Butabarbital Sodium Elixir, 30 mg/5 mLWockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
Start Printed Page 1166
ANDA 085411Phentermine HCl Capsules, 30 mgABC Holding Corp.
ANDA 085511Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 085512Phenazine-35 (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 085550Butabarbital Sodium Tablets, 30 mgCM Bundy Co.
ANDA 085569Chlorothiazide Tablets, 250 mgABC Holding Corp.
ANDA 085587Meclizine Hydrochloride Chewable TabletsCamall Co., Inc., 60950 Van Dyke Ave., P.O. Box 218, Washington, MI 48094.
ANDA 085638Codeine, Aspirin, APAP Formula No. 4 (codeine phosphate, aspirin, and acetaminophen) Capsules, 60 mg/180 mg/150 mgScherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX 75093.
ANDA 085639Codeine, Aspirin, APAP Formula No. 3 (codeine phosphate, aspirin, and acetaminophen) Capsules, 30 mg/180 mg/150 mg  Do.
ANDA 085640Codeine, Aspirin, APAP Formula No. 2 (codeine phosphate, aspirin, and acetaminophen) Capsules, 15 mg/180 mg/150 mg  Do.
ANDA 085672Hydrochlorothiazide Tablets, 50 mgABC Holding Corp.
ANDA 085756Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mgCamall Co., Inc.
ANDA 085766Atropine Sulfate and Diphenoxylate HCl Tablets, 0.025 mg/2.5 mgPrivate Formulations, Inc.
ANDA 085882Duvoid (bethanechol chloride) Tablets, 50 mgChartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920.
ANDA 085888Brompheniramine Maleate TabletsLeiner Health Products, Inc.
ANDA 085891Meclizine HCl Tablets, 25 mgAnabolic, Inc.
ANDA 085895Secobarbital Sodium Capsules, 100 mgEverylife.
ANDA 086008Hydrocortisone and Urea Cream, 1%/10%Bioglan Laboratories, Ltd., 450 Hilltop Rd., Riegelsville, PA 18077.
ANDA 086077Nitrofurazone Ointment, 0.2%Ambix Laboratories, Division of Organics Corp. of America.
ANDA 086079Hydrocortisone Ointment, 1%  Do.
ANDA 086080Hydrocortisone Cream, 1%  Do.
ANDA 086141Tolbutamide Tablets, 500 mgAlra Laboratories, Inc.
ANDA 086260Ona-Mast (phentermine HCl) Tablets, 8 mgMM Mast and Co.
ANDA 086262Duvoid (bethanechol chloride) Tablets, 10 mgChartwell RX Sciences, LLC.
ANDA 086263Duvoid (bethanechol chloride) Tablets, 25 mg  Do.
ANDA 086271Hydrocortisone Cream, 2.5%Ambix Laboratories, Division of Organics Corp. of America.
ANDA 086272Hydrocortisone Ointment, 2.5%  Do.
ANDA 086498Amitriptyline HCl Tablets, 10 mgAlra Laboratories, Inc.
ANDA 086499Amitriptyline HCl Tablets, 50 mg  Do.
ANDA 086500Amitriptyline HCl Tablets, 150 mg  Do.
ANDA 086501Amitriptyline HCl Tablets, 100 mg  Do.
ANDA 086502Amitriptyline HCl Tablets, 25 mg  Do.
ANDA 086503Amitriptyline HCl Tablets, 75 mg  Do.
ANDA 086511Ona-Mast (phentermine HCl) Capsules, 30 mgMM Mast and Co.
ANDA 086516Ona-Mast (phentermine HCl) Capsules, 30 mg  Do.
ANDA 086550X-Trozine (phendimetrazine tartrate) Tablets, 35 mgShire Richwood, Inc., 7900 Tanners Gate Dr., Suite 200, Florence, KY 41042.
ANDA 086551X-Trozine (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 086552X-Trozine (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 086553X-Trozine (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 086554X-Trozine (phendimetrazine tartrate) Tablets, 35 mg  Do.
ANDA 086735Phentermine HCl Capsules, 15 mgCamall Co., Inc.
ANDA 086748Theophylline Elixir, 80 mg/15 mLWockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 086766Nitrofurazone Ointment, 0.2%Wendt Laboratories, Inc.
ANDA 087081Nitrofurazone Topical Solution, 0.2%  Do.
ANDA 087226Phentermine HCl Capsules, 30 mgCamall Co., Inc.
ANDA 087371X-Trozine L.A. (phendimetrazine tartrate) Extended-Release Capsules, 105 mgShire Richwood, Inc.
ANDA 087392Aminophylline Injection, 25 mg/mLPharma Serve, Inc., Subsidiary of Torigian Laboratories, 218-20 98th Ave., Queens Village, NY 11429.
ANDA 087394X-Trozine (phendimetrazine tartrate) Capsules, 35 mgShire Richwood, Inc.
ANDA 087442Neosar (cyclophosphamide) for Injection, 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vialBedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146.
ANDA 087487Melfiat-105 (phendimetrazine tartrate) Extended-Release Capsules, 105 mgNumark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837.
ANDA 087636Tropicamide Ophthalmic Solution, 0.5%Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories.
ANDA 087637Tropicamide Ophthalmic Solution, 1%  Do.
ANDA 087681Paracaine (proparacaine HCl) Ophthalmic Solution, 0.5%Optopics Laboratories Corp.
ANDA 087764Oby-Trim (phentermine HCl) Capsules, 30 mgShire Richwood, Inc.
ANDA 087932Triamcinolone Acetonide Cream, 0.025%Ambix Laboratories, Division of Organics Corp. of America.
ANDA 088786Sodium Polystyrene Sulfonate USP Powder, 453.6 g/bottleWockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
Start Printed Page 1167
ANDA 088897Promethazine VC Plain (phenylephrine HCl and promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL  Do.
ANDA 089141Aerolate (theophylline) Oral Solution, 150 mg/15 mLFleming and Co. Pharmaceuticals, Inc.
ANDA 089417Methocarbamol Tablets USP, 500 mgAmerican Therapeutics, Inc.
ANDA 089418Methocarbamol Tablets USP, 750 mg  Do.
ANDA 089478Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg  Do.
ANDA 089479Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg  Do.
ANDA 089480Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg  Do.
ANDA 089514Trihexyphenidyl HCl Elixir, 2 mg/5 mLPharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona, NY 10970.
ANDA 089726Prednisone Oral Solution, 5 mg/5 mLWockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.
ANDA 204472Fludeoxyglucose F-18 Injection USP, 20-300 mCi/mLMIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm. PS049, Stanford, CA 94305.
ANDA 204517Sodium Fluoride F-18 Injection, 10-200 mCi/mL  Do.
ANDA 204535Ammonia N-13 Injection USP, 3.75-37.5 mCi/mL  Do.

Therefore, under §§ 314.150(b)(1) and 314.200 (21 CFR 314.150(b)(1) and 314.200), notice is given to the holders of the approved ANDAs listed in the table and to all other interested persons that the Director of CDER proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of the ANDAs and all amendments and supplements to them on the grounds that the ANDA holders have failed to submit reports required under §§ 314.81 and 314.98.

In accordance with section 505 of the FD&C Act and part 314 (21 CFR part 314), the ANDA holders are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for an administrative determination, all issues relating to the legal status of the drug products covered by these ANDAs.

An ANDA holder who decides to seek a hearing must file the following: (1) A written notice of participation and request for a hearing (see DATES and ADDRESSES) and (2) the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES and ADDRESSES). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, the notice of participation and request for a hearing; the information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and in 21 CFR part 12.

The failure of an ANDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that ANDA holder not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the ANDAs and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the ANDAs, and the drug products may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved ANDA is subject to regulatory action at any time.

A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing.

All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs.

Start Signature

Dated: January 3, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-00120 Filed 1-8-20; 8:45 am]

BILLING CODE 4164-01-P