2024-26913. Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications

Table 1—NDAs for Which Approval Is Withdrawn

Application No.	Drug	Applicant
NDA 012541	Depo-Provera (medroxyprogesterone acetate) Injectable, 100 milligrams (mg)/milliliter (mL) and 400 mg/mL	Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
NDA 012945	Diamox (acetazolamide) Extended-Release Capsules, 500 mg	Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Parkway, West Chester, PA 19380.
NDA 013132	Deca-Durabolin (nandrolone decanoate) Injectable, 50 mg/mL,100 mg/mL, and 200 mg/mL	Woodward Specialty, LLC, 16825 West 116th St., Lenexa, KS 66219.
NDA 018063	Corgard (nadolol) Tablets, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg	USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241.
NDA 019950	Diflucan in Dextrose 5% in Plastic Container (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL Diflucan in Sodium Chloride 0.9% (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL Diflucan in Sodium Chloride 0.9% in Plastic Container (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL	Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
NDA 020001	Capex (fluocinolone acetonide) Shampoo, 0.01%	Galderma Laboratories, L.P., 2001 Ross Ave., Suite 1600, Dallas, TX 75201.
NDA 020938	Mobic (meloxicam) Tablets, 7.5 mg and 15 mg	Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield, CT 06877.
NDA 021333	Minirin (desmopressin acetate) Metered Nasal Spray, 0.01 mg/spray	Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054.
NDA 021372	Aloxi (palonosetron hydrochloride (HCl)) Injectable, Equivalent to (EQ) 0.075 mg base/1.5 mL and EQ 0.25 mg base/5 mL	Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc., 200 Wood Ave. South, Suite 100, Iselin, New Jersey 08830.
NDA 021689	Nexium IV (esomeprazole sodium) Injectable, EQ 20 mg base/vial and EQ 40mg base/vial	AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
NDA 021861	Patanase (olopatadine HCl) Metered Nasal Spray, 0.665 mg/spray	Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
NDA 022025	Totect (dexrazoxane HCl) Injectable, EQ 500 mg base/vial	Clinigen, Inc., 45 Great Valley Parkway, Malvern, PA 19355.
NDA 022204	Gelnique (oxybutynin chloride) Transdermal Gel, 10% (100 mg/packet)	AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
NDA 022233	Aloxi (palonosetron HCl) Capsules, EQ 0.5 mg base	Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc.
NDA 022502	Differin (adapalene) Lotion, 0.1%	Galderma Laboratories.
NDA 022524	Zuplenz (ondansetron) Oral Film, 4 mg and 8 mg	Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 07059.
NDA 050297	Ery-Ped (erythromycin ethylsuccinate) Chewable Tablets, EQ 200 mg base E.E.S. (erythromycin ethylsuccinate) Chewable Tablets, EQ 200 mg base	Azurity Pharmaceuticals, Inc., 8 Cabot Rd., Woburn, MA 01801.
NDA 050611	PCE (erythromycin) Coated Particles in Tablets, 333 mg and 500 mg	Do.
NDA 050824	Omeclamox-Pak (amoxicillin Capsules, 500 mg; clarithromycin Tablets, 500 mg; and omeprazole Delayed-Release Capsules, 20 mg)	Cumberland Pharmaceuticals Inc., 1600 West End Ave., Suite 1300, Nashville, TN 37203.
NDA 203667	Minastrin 24 Fe (ethinyl estradiol/norethindrone acetate) Tablets, 0.02 mg/1 mg	Allergan Pharmaceuticals International Ltd. c/o AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
NDA 204427	Kerydin (tavabarole) Topical Solution, 5%	Anacor Pharmaceuticals Inc., 445 Eastern Point Rd., Groton, CT 06340.
NDA 205103	Yosprala (aspirin/omeprazole) Delayed-Release Tablets, 81 mg/40 mg and 325 mg/40 mg	Genus Lifesciences Inc., 514 North 12th St., Allentown, PA 18102.
NDA 205383	Oraltag (iohexol) for Oral Solution, 9.7 gram/bottle	Interpharma Praha AS c/o Otsuka Pharmaceutical Development and Commercialization Inc., 508 Carnegie Center Dr., Princeton, NJ 08540.
NDA 207930	Utibron (glycopyrrolate, indacaterol maleate) Inhalation Powder, 15.6 microgram/inhaler and 27.5 microgram/inhaler	Novartis Pharmaceuticals Corp.
NDA 207923	Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6 microgram/inhaler	Do.
NDA 216951	Jesduvroq (daprodustat) Tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg	GlaxoSmithKline Intellectual Property (No. 2) Ltd. England  c/o GSK, 2929 Walnut St., Suite 1700, Philadelphia, PA 19104.