Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of May 20, 2019.
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FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov.
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The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
|ANDA 070470||Disopyramide Phosphate Capsules USP, Equivalent to (EQ) 100 milligrams (mg) base||Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520.|
|ANDA 070471||Disopyramide Phosphate Capsules USP, EQ 150 mg base||Do.|
|ANDA 070531||Clofibrate Capsules USP, 500 mg||Upsher-Smith Laboratories, LLC, 301 South Cherokee St., Denver, CO 80223.|
|ANDA 070797||Chlorpheniramine Maleate Extended-Release Capsules USP, 12 mg||Aurolife Pharma, LLC.|
|ANDA 070956||Diazepam Tablets USP, 10 mg||Halsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233.|
|ANDA 071128||Haloperidol Tablets USP, 0.5 mg||Cycle Pharmaceuticals, Ltd., c/o Mapi USA, Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504.|
|ANDA 071129||Haloperidol Tablets USP, 1 mg||Do.|
|ANDA 071133||Haloperidol Tablets USP, 20 mg||Do.|
|ANDA 072394||Fenoprofen Calcium Capsules USP, EQ 200 mg base||Aurolife Pharma, LLC.|
|ANDA 072395||Fenoprofen Calcium Capsules USP, EQ 300 mg base||Do.|
|ANDA 072396||Fenoprofen Calcium Tablets USP, EQ 600 mg base||Do.|
|ANDA 072484||Trazodone Hydrochloride (HCl) Tablets USP, 50 mg||Do.|
|ANDA 074024||Ketoprofen Capsules, 50 mg and 75 mg||Do.|
|ANDA 074448||Flurbiprofen Tablets USP, 50 mg and 100 mg||Do.|
|ANDA 078300||Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vial||Mustafa Nevzat Ilac San. A.S. (MN Pharmaceuticals), c/o Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd., suite 450, Schaumburg, IL 60195.|
|ANDA 080655||Meprobamate Tablets USP, 400 mg||Aurolife Pharma, LLC.|
|ANDA 083234||Glutethimide Tablets, 500 mg||Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr. North, Maple Grove, MN 55369.|
|ANDA 084156||Pentobarbital Sodium Capsules, 100 mg||Warner-Lambert Company, 201 Tabor Rd., Morris Plains, NJ 07950.|
|ANDA 084674||Aminophylline Tables USP, 100 mg||Halsey Drug Co., Inc.|
|ANDA 085628||Sulfisoxazole Tablets USP, 500 mg||Aurolife Pharma, LLC.|
|ANDA 085813||Prednisone Tablets USP, 20 mg||Do.|
|ANDA 085844||Sulfamethoxazole Tablets USP, 500 mg||Do.|
|ANDA 085925||Amitriptyline HCl Tablets USP, 50 mg||Halsey Drug Co., Inc.|
|ANDA 085926||Amitriptyline HCl Tablets USP, 75 mg||Do.|
|ANDA 085927||Amitriptyline HCl Tablets USP, 100 mg||Do.|
|ANDA 089057||Cyproheptadine HCl Tablets USP, 4 mg||Do.|
|ANDA 089117||Hydroxyzine HCl Tablets USP, 25 mg||Do.|
|ANDA 089894||Quinidine Gluconate Extended-Release Tablets USP, 324 mg||Aurolife Pharma, LLC.|
|ANDA 089983||Prednisone Tablets USP, 10 mg||Do.|
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|ANDA 089984||Prednisone Tablets USP, 50 mg||Do.|
|ANDA 208991||Piroxicam Capsules USP, 10 mg and 20 mg||Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., suite 201, Berlin, CT 06037.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 20, 2019. Approval of each entire application is withdrawn, including any strengths or products missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on May 20, 2019 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
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Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07833 Filed 4-17-19; 8:45 am]
BILLING CODE 4164-01-P