Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-4563]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple 
                        ( print page 46080)
                        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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: Withdrawal of approval is effective November 2, 2017.
 FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.


SUPPLEMENTARY INFORMATION: The holders of the applications 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 pursuant to 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. Application No.
Drug
ApplicantNDA 014349
Delfen (nonoxynol-9) Contraceptive Foam, 12.5%
Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ 08558.ANDA 019346
Dextrose 60% Injection USP in Plastic Container
Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. H2-2, Lake Forest, IL 60045.NDA 019810
Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg
AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg, MD 20878.NDA 020184
Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8 mg
Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH 45227.NDA 022345
Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and 400 mg
GlaxoSmithKline Intellectual Property Management LTD England, c/o GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA 19426.NDA 021712
Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mg
UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.ANDA 040108
Acetazolamide for Injection USP, Equivalent to (EQ) 500 mg base/vial
Hospira, Inc.ANDA 040206
Digoxin Injection USP, 0.25 mg/milliliter (mL)
Do.ANDA 040527
Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg
Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512.ANDA 040899
Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg
Do.ANDA 060099
Penicillin G Procaine for Injection, 300,000 units/vial and 1,500,000 units/vial
Pfizer Inc., 235 East 42nd St., New York, NY 10017.ANDA 063161
Tobramycin Injection USP, EQ 40 mg base/mL
Hospira, Inc.ANDA 070171
Naloxone HCl Injection USP, 0.02 mg/mL
Do.ANDA 070186
Disopyramide Phosphate Capsules USP, EQ 100 mg base
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 070233
Propranolol HCl Tablets USP, 20 mg
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 070255
Naloxone HCl Injection, 0.4 mg/mL
Hospira, Inc.ANDA 070698
Methyldopate HCl Injection USP, 50 mg/mL, ADD-Vantage Vial
Do.ANDA 070699
Methyldopate HCl Injection USP, 50 mg/mL, Fliptop Vial
Do.ANDA 070739
Verapamil HCl Injection, 2.5 mg/mL, 2 mL Abbojet-PA Syringe
Do.ANDA 070740
Verapamil HCl Injection, 2.5 mg/mL, 4 mL Abbojet Syringe Vial
Do.ANDA 070803
Enflurane USP, 99.9%
Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., D389, Bldg. J45-2, Abbott Park, IL 60064.ANDA 070888
Aminocaproic Acid Injection USP, 250 mg/mL
Hospira, Inc.ANDA 071357
Tolazamide Tablets USP, 100 mg
Sun Pharmaceutical Industries, Inc.ANDA 071438
Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 mL
Hospira, Inc.ANDA 071618
Ritodrine HCl Injection USP, 10 mg/mL
Do.ANDA 071619
Ritodrine HCl Injection USP, 15 mg/mL
Do.ANDA 071982
Droperidol and Fentanyl Citrate Injection, 2.5 mg/mL and EQ 0.05 mg base/mL
Do.ANDA 072321
Pancuronium Bromide Injection, 2 mg/mL
Do.ANDA 073199
Sulfamethoxazole and Trimethoprim Injection USP, 80 mg/mL and 16 mg/mL
Do.ANDA 073310
Tolmetin Sodium Tablets USP, EQ 200 mg base
Sun Pharmaceutical Industries, Inc.ANDA 073428
CO-LAV (polyethylene glycol 3350 and electrolytes) for Oral Suspension
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.ANDA 073433
GO-EVAC (polyethylene glycol 3350 and electrolytes) for Oral Suspension
Do.ANDA 073677
Carbastat (carbachol) Intraocular Solution, 0.01%
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.ANDA 074168
Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 074280
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL
Hospira, Inc.ANDA 074296
Cimetidine HCl Injection, EQ 300 mg base/2 mL (Carpuject)
Do.ANDA 074412
Cimetidine HCl Injection, EQ 300 mg base/2 mL
Do.ANDA 074422
Cimetidine HCl Injection, EQ 300 mg base/2 mL, ADD-Vantage Vial
Do.ANDA 074468
Cimetidine HCl in Sodium Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg base/100 mL, EQ 360 mg/100 mL, and EQ 480 mg base/100 mL
Do.ANDA 074620
Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/mL
Do.ANDA 074758
Acyclovir for Injection USP, EQ 500 mg base/vial and EQ 1 gram (g) base/vial
Do.( print page 46081)ANDA 074801
Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL
Do.ANDA 075385
Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 075453
Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base
Do.ANDA 076883
Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg
Teva Pharmaceuticals USA, Inc.ANDA 077052
Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base
Sun Pharmaceutical Industries, Inc.ANDA 077937
Meloxicam Tablets, 7.5 mg and 15 mg
Do.ANDA 078081
Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg base, and EQ 10 mg base
Do.ANDA 078158
Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL
Hospira, Inc.ANDA 078483
Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg and 12.5 mg
Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC 27703.ANDA 080136
Isoniazid Tablets, 100 mg
Sun Pharmaceutical Industries, Inc.ANDA 080209
Prednisone Tablets USP, 5 mg
Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD 21045.ANDA 080224
Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 mg/100 mL
Hospira, Inc.ANDA 083345
Potassium Chloride for Injection Concentrate USP, 1 milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL
Do.ANDA 083808
Quinidine Sulfate Tablets USP, 200 mg
Contract Pharmacal Corp., c/o SciRegs International Inc.ANDA 084623
Chlordiazepoxide HCl Capsules USP, 10 mg
Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369.ANDA 084644
Chlordiazepoxide HCl Capsules USP, 5 mg
Do.ANDA 084710
Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g
Pfizer Inc.ANDA 085061
Folic Acid Tablets USP, 1 mg
Contract Pharmacal Corp., c/o SciRegs International Inc.ANDA 085933
Phentermine HCl Tablets USP
Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.ANDA 086494
Chlordiazepoxide HCl Capsules, 25 mg
Teva Pharmaceuticals USA, Inc.ANDA 086821
Hydroxyzine HCl Injection USP, 50 mg/mL
Hospira, Inc.ANDA 087416
Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject
Do.ANDA 087546
Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject
Do.ANDA 087862
Hydroxyzine HCl Tablets USP, 100 mg
Sun Pharmaceutical Industries, Inc.ANDA 088147
Aminophylline in Sodium Chloride 0.45% Injection, 100 mg/100 mL and 200 mg/100 mL
Hospira, Inc.ANDA 088367
Lidocaine HCl Injection USP, 10%
Do.ANDA 088542
Lidocaine HCl Injection USP, 4%
Do.ANDA 089162
Cyclopentolate HCl Ophthalmic Solution, 1%
Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC-45, Fort Worth, TX 76134.ANDA 089347
Diatrizoate Meglumine and Diatrizoate Sodium Injection USP, 66%; 10%
Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ 08831.ANDA 089393
Glycopyrrolate Injection USP, 0.2 mg/mL
Hospira, Inc.ANDA 089488
Diphenhydramine HCl Capsules, 25 mg
Sun Pharmaceutical Industries, Inc.ANDA 089521
Phenytoin Sodium Injection USP, 50 mg/mL, Ampule
Hospira, Inc.ANDA 089537
Procainamide HCl Injection USP, 500 mg/mL, Carpuject
Do.ANDA 089744
Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject
Do.ANDA 089915
Leucovorin Calcium for Injection, EQ 100 mg base/vial
Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618.NDA 202258
Victrelis (boceprevir) Capsules, 200 mg
Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.NDA 203093
Vitekta (elvitegravir) Tablets, 85 mg and 150 mg
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective November 2, 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 the table that are in inventory on the date that this notice becomes effective (see 
                    **DATES**
                    ) 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 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.


[FR Doc. 2017-21177 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P