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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-5526]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: *Applied Date:*
                         October 23, 2017.
 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.


SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process 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 abbreviated application under § 314.150(c) is without prejudice to refiling. Table 1
Application No.
Drug
ApplicantANDA 061071
Tetracycline Hydrochloride (HCl) Tablets, 250 milligrams (mg)
Department of Health and Human Services, Supply Service Center, PSC Bldg. 14 Boiler House Rd., Perry Point, MD 21902.ANDA 062279
Grifulvin V (griseofulvin microsize) Tablets USP,125 mg, 250 mg, and 500 mg
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.ANDA 062398
Cephalexin Capsules, 250 mg and 500 mg
Department of Health and Human Services, Supply Service Center, PSC Bldg. 14 Boiler House Rd., Perry Point, MD 21902.ANDA 062756
Primaxin (cilastatin sodium and imipenem) for Injection, Equivalent to (EQ) 250 mg base/vial; 250 mg/vial and EQ 500 mg base/vial; 500 mg/vial
Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.ANDA 062814
Gentamicin Sulfate in 0.9% Sodium Chloride Injection, EQ 0.8 mg base/milliliter (mL), EQ 1.2 mg base/mL, EQ 1.4 mg base/mL, EQ 1.6 mg base/mL, EQ 1.8 mg base/mL, EQ 2 mg base/mL, EQ 2.4 mg base/mL, EQ 40 mg base/100 mL, EQ 60 mg base/100 mL, EQ 70 mg base/100 mL, EQ 80 mg base/100 mL, EQ 90 mg base/100 mL, EQ 100 mg base/100 mL, and EQ 120 mg base/100 mL
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109.ANDA 063239
Rocephin (ceftriaxone sodium) for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, and EQ 1 gram (g) base/vial
Hoffmann-La Roche, Inc., c/o Genentech Inc., 1 DNA Way, MS 241B, South San Francisco, CA 94080.ANDA 064127
Erythromycin Topical Solution, 2%
Renaissance Pharma, Inc., 411 South State St., Suite E-100, Newton, PA 18940.ANDA 064146
Amikacin Sulfate in Sodium Chloride 0.9% Injection, EQ 500 mg base/100 mL
Hospira, Inc., Subsidiary of Pfizer Inc., 375 N. Field Dr., Lake Forest, IL 60045.ANDA 070598
Metoclopramide HCl Tablets, EQ 10 mg base
Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc.ANDA 072080
Furosemide Injection USP, 10 mg/mL
Hospira, Inc., Subsidiary of Pfizer Inc.ANDA 074601
Dipyridamole Injection, 5 mg/mL
Do.ANDA 074720
Acyclovir Sodium Injection, EQ 25 mg base/mL
Do.ANDA 076564
Adenosine Injection USP, 3 mg/mL
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 078211
Quinapril HCl and Hydrochlorothiazide Tablets, EQ 10 mg base/12.5 mg, EQ 20 mg base/12.5 mg, and EQ 20 mg base/25 mg
Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.ANDA 078935
Tramadol HCl Tablets USP, 50 mg
Northstar Healthcare Holdings, c/o Quality Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963.ANDA 080810
Halothane USP, 99.99%
Halocarbon Products Corp., 1100 Dittman Ct., North Augusta, SC 29841.ANDA 085458
Dexamethasone Tablets USP, 0.5 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 085883
Acetaminophen and Codeine Phosphate Oral Suspension USP, 120 mg/5 mL and 12 mg/5 mL
Actavis Mid Atlantic LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 085884
Cortisone Acetate Tablets USP, 25 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 086179
Carisoprodol Tablets USP, 350 mg
Do.ANDA 086440
Atropine Sulfate and Diphenoxylate HCl Capsules, 0.025 mg/2.5 mg
Catalent Pharma Solutions, Inc., 2725 Scherer Dr. North, St. Petersburg, FL 33716.ANDA 087535
Methylprednisolone Sodium Succinate for Injection USP, EQ 500 mg base/vial and EQ 1 g base/vial
Organon USA, Inc., Subsidiary of Merck and Co., Inc., 126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 07065.ANDA 087711
Dexamethasone Acetate Injectable Suspension USP, EQ 16 mg base/mL
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 088346
Heparin Lock Flush Solution USP and 0.9% Sodium Chloride Injection USP, 10 USP heparin units/mL and 100 USP heparin units/mL
Hospira, Inc.ANDA 088852
Chlorpropamide Tablets USP, 100 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.( print page 44187)ANDA 091201
Meropenem for Injection USP, 500 mg/vial and 1 g/vial
Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.ANDA 200156
Armodafinil Tablets, 100 mg and 200 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
 Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn, effective October 23, 2017. 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 table 1 that are in inventory on the date that this notice becomes effective (see the 
                    **DATES**
                     section) 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: September 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.


[FR Doc. 2017-20107 Filed 9-20-17; 8:45 a.m.] BILLING CODE 4164-01-P