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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-0002]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of February 16, 2018.
 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, 
                        *Trang.Tran@fda.hhs.gov.*


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 application or abbreviated application under § 314.150(c) is without prejudice to refiling. Table 1—ANDAs for Which FDA Is Withdrawing Approval
Application No.
Drug
ApplicantANDA 060577
Mycostatin (nystatin) Vaginal Tablets, 100,000 units
Delcor Asset Corp., 411 South State St., Suite E-100, Newtown, PA 18940.ANDA 063302
Cefamandole Nafate for Injection
ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17 North, Paramus, NJ 07653.ANDA 070462
Diazepam Tablets USP, 2 milligrams (mg)
Virtus Pharmaceuticals, 12 Penns Trail, Newtown, PA 18940.ANDA 070463
Diazepam Tablets USP, 5 mg
Do.ANDA 070998
Potassium Chloride Extended-Release Tablets, 8 milliequivalents (mEq)
Future Pak, Ltd., 28115 Lakeview Dr., Wixom, MI 48393.ANDA 070999
Potassium Chloride Extended-Release Tablets, 10 mEq
Do.( print page 2456)ANDA 075375
Diltiazem Hydrochloride (HCl) Injection, 5 mg/milliliter (mL)
Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.ANDA 076911
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, and 15 mg
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.ANDA 077102
Calcitriol Injection, 0.001 mg/mL
Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite 450, Schaumburg, IL 60195.ANDA 084656
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.ANDA 087977
Diphenhydramine HCl Capsules, 25 mg
LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788.ANDA 088676
Methylprednisolone Sodium Succinate for Injection USP, Equivalent to 40 mg base/vial
LyphoMed, Division of Fujisawa USA, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160.ANDA 089080
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg
Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.ANDA 089183
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg
Superpharm Corp., 1769 Fifth Ave., Bayshore, NY 11706.ANDA 089253
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg
Do.ANDA 089219
Procainamide HCl Capsules USP, 250 mg, 375 mg, and 500 mg
IDT Australia, Ltd., c/o Facet Life Sciences, Inc., 6122 Stone Wolfe Dr., Glen Carbon, IL 62034.ANDA 089254
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg
Do.ANDA 089369
Procainamide HCl Extended-Release Tablets USP, 250 mg, 500 mg, and 750 mg
Do.ANDA 089481
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg
American Therapeutics, Inc., 75 Carlough Rd., Bohemia, NY 11716.ANDA 089482
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg
Do.ANDA 089483
Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg
Do.ANDA 206711
Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg
Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., One Grande Commons, 440 U.S. Highway 22 East, Suite 150, Bridgewater, NJ 08807.
 Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 16, 2018. 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: January 11, 2018. Leslie Kux, Associate Commissioner for Policy.


[FR Doc. 2018-00695 Filed 1-16-18; 8:45 am] BILLING CODE 4164-01-P