2021-00833. TG United Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES:

Approval is withdrawn as of February 16, 2021.

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, 240-402-6980, [e-mail].

SUPPLEMENTARY INFORMATION:

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.

Application No.	Drug	Applicant
ANDA 040083	Phentermine Hydrochloride (HCl) Capsules, 30 milligrams (mg)	TG United Inc., 16275 Aviation Loop Dr., Brooksville, FL 34604.
ANDA 040451	Cyanocobalamin Injection, 1 mg/milliliters (mL)	Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
ANDA 040518	Bethanechol Chloride Tablets, 50 mg	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC, 6451 W. Main St., Morton Grove, IL 60053.
ANDA 040532	Bethanechol Chloride Tablets, 5 mg	Do.
ANDA 060347	Tetracycline HCl Capsules, 250 mg	Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
ANDA 060478	Neomycin Sulfate Ophthalmic Ointment	Pfizer Inc., 235 East 42nd St., New York, NY 10017.
ANDA 065266	Clarithromycin Tablets, 250 mg and 500 mg	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.
ANDA 065281	Doxycycline Hyclate Delayed Release Capsules, Equivalent to (EQ) 75 mg base; EQ 100 mg base	Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 075208	Ranitidine HCl Tablets, EQ 150 mg base; EQ 300 mg base	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.
ANDA 075822	Loratadine Orally Disintegrating Tablets, 10 mg	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, 184 Liberty Corner Rd., Suite 200, Warren, NJ 07059.
ANDA 076760	Ranitidine HCl Tablets, EQ 75 mg base	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.
ANDA 076849	Vinorelbine Tartrate Injection, EQ 10 mg base/mL	Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 077432	Carboplatin Injection, 50 mg/5 mL(10 mg/mL), 150 mg/15 mL (10 mg/mL), and 450 mg/45 mL (10 mg/mL)	Do.
ANDA 078500	Amlodipine Besylate Tablets, EQ 2.5 mg base; EQ 5 mg base; EQ 10 mg base	Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.
ANDA 084041	Chlordiazepoxide HCl Capsules, 10 mg	Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 084678	Chlordiazepoxide HCl Capsules, 5 mg	Do.
ANDA 084679	Chlordiazepoxide HCl Capsules, 25 mg	Do.
ANDA 088508	Homatropine Methylbromide; Hydrocodone Bitartrate Tablets, 1.5 mg; 5 mg	King Pharmaceuticals Research and Development, LLC, 4000 Centregreen Way, Suite 300, Cary, NC 27513.
ANDA 089953	Thioridazine HCl Tablets, 10 mg, 25 mg, 50 mg, and 100 mg	Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
ANDA 090094	Didanosine Delayed Release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg	Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520.
ANDA 090394	Iopamidol Injection, 61% and 76%	Sanochemia Corporation USA, 9201 University City Blvd., c/o Countervail Corp., Charlotte, NC 08876.
ANDA 091302	Fludrocortisone Acetate Tablets, 0.1 mg	Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 203959	Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg	Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 425 Privet Rd., Horsham, PA 19044.
ANDA 204243	Indomethacin Extended Release Capsules, 75 mg	Aurobindo Pharma USA, Inc.
ANDA 206061	Pravastatin Sodium Tablets, 20 mg, 40 mg, and 80 mg	Hisun Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.
ANDA 206857	Tiagabine HCl Tablets, 2 mg, 4 mg, 12 mg, and 16 mg	Wilshire Pharmaceuticals, Inc., 6 Concourse Pkwy., Suite 1800, Atlanta, GA 30328.
ANDA 209076	Ibuprofen Tablets, 200 mg	Ultra Tab Laboratories, Inc., 50 Toc Dr., Highland, NY 12528.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of February 16, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms 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 February 16, 2021 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.

Dated: January 11, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.