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Lederle Laboratories et al.; Withdrawal of Approval of 12 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 12 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of June 11, 2021.

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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,

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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.

Application No.DrugApplicant
ANDA 060164Nystatin OintmentLederle Laboratories, Division of American Cyanamid Co., P.O. Box 8299, Pearl River, NY 10965.
ANDA 060521Humatin (paromomycin sulfate) Capsules, Equivalent to (EQ) 250 milligrams (mg)/baseKing Pharmaceuticals, 501 5th St., Bristol, TN 37620.
ANDA 061034Lincomycin Hydrochloride (HCl)The Upjohn Co. (formerly Pharmacia and Upjohn Co.), 7000 Portage Rd., Kalamazoo, MI 49001.
ANDA 061652OxytetracyclineParke Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
ANDA 061701TetracyclineWyeth Pharmaceuticals, 1211 Sherwood Ave., Richmond, VA 23220.
ANDA 062032Erypar (erythromycin stearate) Tablets, EQ 250 mg/base and EQ 500 mg/baseParke Davis.
ANDA 076490Lithium Carbonate Extended-Release Tablets, 450 mgHikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 083001Triamcinolone Acetonide FoamLederle Laboratories.
ANDA 084803Chlorpromazine HCl Tablets, 10 mg  Do.
ANDA 087635Butalbital; Aspirin; Phenacetin; Caffeine, Tablets  Do.
ANDA 090102Ranitidine HCl Syrup, EQ 15 mg base/millilitersTorrent Pharma Inc., 150 Allen Rd., Suite 102, Basking Ridge, NJ 07920.
ANDA 206736Rifampin for Injection, 600 mg/vialWatson Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 11, 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 June 11, 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.

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Dated: May 5, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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[FR Doc. 2021-09980 Filed 5-11-21; 8:45 am]