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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-N-0079]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of March 4, 2022.
 FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137, 
                        *Kimberly.Lehrfeld@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: 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 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 006134
Dolophine (methadone hydrochloride (HCl)) Tablets, 5 milligrams (mg), and 10 mg
Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd., Columbus, OH 43228.Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter (mL)NDA 006882
Phisohex (hexachlorophene) Emulsion, 3%
Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807.NDA 009818
Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg
Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017.NDA 012301
Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.NDA 013416
Norgesic (orphenadrine citrate, aspirin, and caffeine) Tablets, 25 mg/385 mg/30 mg
Bausch Health US, LLC.Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mgNDA 014228
Spandin (aspirin and sodium salicylate) Time-released Tablets, 7.5 grains/2.5 grains
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059.NDA 016194
Talwin (pentazocine lactate) Injection, equivalent to (EQ) 30 mg base/mL
Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.NDA 016418
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 90 mg
Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New York, NY 10017.NDA 016704
Resectisol (mannitol) Irrigation Solution, 5 grams (g)/100 mL
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109.NDA 016762
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg
Wyeth Pharmaceuticals LLC.NDA 016954
Micronor (norethindrone) Tablets, 0.35 mg
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.NDA 017013
Sodium Chloride Injection, 20 g/100 mL
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific.NDA 017683
Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg
Wyeth Pharmaceuticals LLC.NDA 018423
Hibiclens (chlorhexidine gluconate) Sponge, 4%
Mölnlycke Health Care, 5445 Triangle Pkwy., Suite 400, Peachtree Corners, GA 30092.NDA 018703
Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and EQ 300 mg base
GlaxoSmithKline Intellectual Property Ltd. England, c/o GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA 19112.NDA 019387
Profenal (suprofen) Ophthalmic Solution, 1%
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134-2099.NDA 019530
Ucephan (sodium benzoate and sodium phenylacetate) Solution, 100 mg/mL; 100 mg/mL
B. Braun Medical Inc.NDA 019675
Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL
GlaxoSmithKline Intellectual Property Ltd. England, c/o GlaxoSmithKline.NDA 019814
Betagan (levobunolol HCl) Ophthalmic Solution, 0.25%
Allergan, Inc.NDA 019927
Nizoral (ketoconazole) Shampoo, 2%
Janssen Pharmaceuticals, Inc.( print page 5828)NDA 020037
Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1%
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936-1080.NDA 021169
Razadyne (galantamine hydrobromide) Tablets, EQ 4 mg base, EQ 8 mg base, and EQ 12 mg base
Janssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.NDA 021204
Starlix (nateglinide) Tablets, 60 mg, and 120 mg
Novartis Pharmaceuticals Corp.NDA 021406
Fortical (calcitonin-salmon recombinant) Nasal Spray, 200 International Units/Spray
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369.NDA 021860
Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ 15 mg base, and EQ 20 mg base
Allergan Pharmaceuticals International Ltd., c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940.NDA 202833
Picato (ingenol mebutate) Gel, 0.015%, and 0.05%
LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda Farms, Madison, NJ 07940.NDA 202880
Zohydro ER (hydrocodone bitartrate) Extended-release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg
Recro Gainesville LLC, 1300 Gould Dr., Gainesville, GA 30504.NDA 204683
Khedezla (desvenlafaxine) Extended-Release Tablets, 50 mg, and 100 mg
Osmotica Pharmaceutical US LLC, 400 Crossing Blvd., Bridgewater, NJ 08807.NDA 207916
Cetylev (acetylcysteine) Effervescent Tablets, 500 mg, and 2.5 g
Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite 1800, Atlanta, GA 30328.
 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 4, 2022. 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 March 4, 2022 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 25, 2022. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2022-02059 Filed 2-1-22; 8:45 am] BILLING CODE 4164-01-P