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Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of June 24, 2019.

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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,

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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 Start Printed Page 23796opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
ANDA 040524Promethazine Hydrochloride (HCl) Injection USP, 25 milligrams (mg)/milliliter (mL) and 50 mg/mLBedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 070857Trazodone HCl Tablets USP, 50 mgWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 070987Diazepam Tablets USP, 2 mgHalsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233.
ANDA 070996Diazepam Tablets USP, 5 mg  Do.
ANDA 071717Flurazepam HCl Capsules USP, 15 mg and 30 mgAurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520.
ANDA 071751Methyldopa Tablets USP, 125 mgHalsey Drug Co., Inc.
ANDA 071752Methyldopa Tablets USP, 250 mg  Do.
ANDA 077190Milrinone Lactate Injection, EQ 1 mg base/mLGland Pharma, Ltd., c/o INC Research, LLC, 4800 Falls of Neuse Rd., Suite 600, Raleigh, NC 27609.
ANDA 077703Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vialSun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512.
ANDA 080300Prednisone Tablets USP, 5 mgHalsey Drug Co., Inc.
ANDA 080961Chlorpheniramine Maleate Tablets USP, 4 mgAurolife Pharma, LLC.
ANDA 083453Niacin Tablets USP, 500 mgHalsey Drug Co., Inc.
ANDA 083629Kloromin (chlorpheniramine maleate) Tablets USP, 4 mg  Do.
ANDA 083930Dextroamphetamine Sulfate Tablets USP, 10 mg  Do.
ANDA 084676Secobarbital Sodium Capsules USP, 100 mg  Do.
ANDA 085088Hydralazine HCl Tablets USP, 50 mgUpsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 085219Hydrochlorothiazide Tablets, 50 mgAurolife Pharma, LLC.
ANDA 085923Amitriptyline HCl Tablets USP, 10 mgHalsey Drug Co., Inc.
ANDA 087279Butalbital, Aspirin, and Caffeine TabletsSandoz, Inc., 227-15 North Conduit Ave., Laurelton, NY 11413.
ANDA 088116Myfed (pseudoephedrine HCl and triprolidine HCl) Syrup, 30 mg/5 mL and 1.25 mg/5 mLUSL Pharma, LLC, 301 South Cherokee St., Denver, CO 80223.
ANDA 088725Chlorpropamide Tablets USP, 100 mgAurolife Pharma, LLC.
ANDA 089130Hydralazine HCl Tablets USP, 25 mgHalsey Drug Co., Inc.
ANDA 089178Hydralazine HCl Tablets USP, 100 mg    Do.
ANDA 201484Levofloxacin Tablets, 250 mg, 500 mg, and 750 mgWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 24, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently 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 June 24, 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: May 20, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-10809 Filed 5-22-19; 8:45 am]