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Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 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 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of May 20, 2019.

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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 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 070470Disopyramide Phosphate Capsules USP, Equivalent to (EQ) 100 milligrams (mg) baseAurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520.
ANDA 070471Disopyramide Phosphate Capsules USP, EQ 150 mg baseDo.
ANDA 070531Clofibrate Capsules USP, 500 mgUpsher-Smith Laboratories, LLC, 301 South Cherokee St., Denver, CO 80223.
ANDA 070797Chlorpheniramine Maleate Extended-Release Capsules USP, 12 mgAurolife Pharma, LLC.
ANDA 070956Diazepam Tablets USP, 10 mgHalsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233.
ANDA 071128Haloperidol Tablets USP, 0.5 mgCycle Pharmaceuticals, Ltd., c/o Mapi USA, Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504.
ANDA 071129Haloperidol Tablets USP, 1 mgDo.
ANDA 071133Haloperidol Tablets USP, 20 mgDo.
ANDA 072394Fenoprofen Calcium Capsules USP, EQ 200 mg baseAurolife Pharma, LLC.
ANDA 072395Fenoprofen Calcium Capsules USP, EQ 300 mg baseDo.
ANDA 072396Fenoprofen Calcium Tablets USP, EQ 600 mg baseDo.
ANDA 072484Trazodone Hydrochloride (HCl) Tablets USP, 50 mgDo.
ANDA 074024Ketoprofen Capsules, 50 mg and 75 mgDo.
ANDA 074448Flurbiprofen Tablets USP, 50 mg and 100 mgDo.
ANDA 078300Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vialMustafa Nevzat Ilac San. A.S. (MN Pharmaceuticals), c/o Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd., suite 450, Schaumburg, IL 60195.
ANDA 080655Meprobamate Tablets USP, 400 mgAurolife Pharma, LLC.
ANDA 083234Glutethimide Tablets, 500 mgUpsher-Smith Laboratories, LLC, 6701 Evenstad Dr. North, Maple Grove, MN 55369.
ANDA 084156Pentobarbital Sodium Capsules, 100 mgWarner-Lambert Company, 201 Tabor Rd., Morris Plains, NJ 07950.
ANDA 084674Aminophylline Tables USP, 100 mgHalsey Drug Co., Inc.
ANDA 085628Sulfisoxazole Tablets USP, 500 mgAurolife Pharma, LLC.
ANDA 085813Prednisone Tablets USP, 20 mgDo.
ANDA 085844Sulfamethoxazole Tablets USP, 500 mgDo.
ANDA 085925Amitriptyline HCl Tablets USP, 50 mgHalsey Drug Co., Inc.
ANDA 085926Amitriptyline HCl Tablets USP, 75 mgDo.
ANDA 085927Amitriptyline HCl Tablets USP, 100 mgDo.
ANDA 089057Cyproheptadine HCl Tablets USP, 4 mgDo.
ANDA 089117Hydroxyzine HCl Tablets USP, 25 mgDo.
ANDA 089894Quinidine Gluconate Extended-Release Tablets USP, 324 mgAurolife Pharma, LLC.
ANDA 089983Prednisone Tablets USP, 10 mgDo.
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ANDA 089984Prednisone Tablets USP, 50 mgDo.
ANDA 208991Piroxicam Capsules USP, 10 mg and 20 mgBreckenridge 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.

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[FR Doc. 2019-07833 Filed 4-17-19; 8:45 am]