2024-28433. Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Table 1—Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Application No.	Drug name	Active ingredient(s)	Dosage form/route	Strength(s)	Applicant
NDA 008370	BENTYL PRESERVATIVE FREE	Dicyclomine Hydrochloride	Injectable; Injection	10 Milligrams (mg)/Milliliters (mL)	AbbVie.
NDA 012104	KENALOG	Triamcinolone Acetonide	Spray; Topical	0.147 mg/Gram (g)	Sun Pharmaceutical Industries Limited.
NDA 017806	THALLOUS CHLORIDE TL 201	Thallous Chloride TL-201	Injectable; Intravenous	1 Millicurie (mCi)/mL; 2 mCi/mL	Lantheus.
NDA 017823	HALOG	Halcinonide	Solution; Topical	0.10%	Sun Pharmaceutical Industries Limited.
NDA 018849	LIDEX	Fluocinonide	Solution; Topical	0.05%	Alvogen.
NDA 020551	NIMBEX	Cisatracurium Besylate	Injectable; Injection	Equivalent to (EQ) 2 mg Base/mL	AbbVie.
NDA 020551	NIMBEX PRESERVATIVE FREE	Cisatracurium Besylate	Injectable; Injection	EQ 2 mg Base/mL; EQ 10 mg Base/mL	AbbVie.
( print page 96655)
NDA 020837	XOPENEX	Levalbuterol Hydrochloride	Solution; Inhalation	EQ 0.0103% Base; EQ 0.021% Base; EQ 0.042% Base; EQ 0.25% Base	Hikma.
NDA 020857	COMBIVIR	Lamivudine; Zidovudine	Tablet; Oral	150 mg; 300 mg	Viiv Health Care.
NDA 020977	ZIAGEN	Abacavir Sulfate	Tablet; Oral	EQ 300 mg Base	Viiv Health Care.
NDA 021205	TRIZIVIR	Abacavir Sulfate, Lamivudine, Zidovudine	Tablet; Oral	EQ 300 mg Base, 150 mg, 300 mg	Viiv Health Care.
NDA 021223	ZOMETA	Zoledronic Acid	Injectable; Intravenous	EQ 4 mg Base/100 mL; EQ 4 mg Base/5 mL	Novartis.
NDA 021548	LEXIVA	Fosamprenavir Calcium	Tablet; Oral	EQ 700 mg Base	Viiv Health Care.
NDA 021695	ANTARA (MICRONIZED)	Fenofibrate	Capsule; Oral	90 mg	Lupin.
NDA 021738	EXTINA	Ketoconazole	Aerosol, Foam; Topical	2%	Mylan.
NDA 021861	PATANASE	Olopatadine Hydrochloride	Spray, Metered; Nasal	0.665 mg/Spray	Novartis.
NDA 022128	SELZENTRY	Maraviroc	Tablet; Oral	25 mg; 75 mg	Viiv Health Care.
NDA 022350	ONGLYZA	Saxagliptin Hydrochloride	Tablet; Oral	EQ 2.5 mg Base; EQ 5 mg Base	AstraZeneca AB.
NDA 050440	KEFLET	Cephalexin	Tablet; Oral	EQ 250 mg Base; EQ 500 mg Base	Eli Lilly and Company.
NDA 050558	ZINACEF	Cefuroxime Sodium	Injectable; Intramuscular, Intravenous	EQ 750 mg Base/Vial; EQ 1.5 g Base/Vial; EQ 7.5 g Base/Vial	PAI Pharma.
NDA 050567	POLYTRIM	Polymyxin B Sulfate, Trimethoprim Sulfate	Solution/Drops; Ophthalmic	10,000 Units/mL, EQ 1 mg Base/mL	Allergan.
NDA 050588	CEFOTAN	Cefotetan Disodium	Injectable; Injection	EQ 10 g Base/Vial	PAI Pharma.
NDA 050795	DORYX	Doxycycline Hyclate	Tablet, Delayed Release; Oral	EQ 75 mg Base; EQ 150 mg Base	Mayne Pharma.
NDA 200678	KOMBIGLYZE XR	Metformin Hydrochloride, Saxagliptin Hydrochloride	Tablet, Extended Release; Oral	500 mg, EQ 5 mg Base; 1 g, EQ 5 mg Base; 1 g, EQ 2.5 mg Base	AstraZeneca AB.
NDA 201194	OXYCODONE HYDROCHLORIDE	Oxycodone Hydrochloride	Solution; Oral	5 mg/5 mL	VistaPharm, LLC.
NDA 204427	KERYDIN	Tavaborole	Solution; Topical	5%	Anacor Pharmaceuticals, Inc.
NDA 204592	ZORVOLEX	Diclofenac	Capsule; Oral	35 mg	Zyla.
NDA 204790	TIVICAY	Dolutegravir Sodium	Tablet; Oral	EQ 10 mg Base; EQ 25 mg Base	Viiv Health Care.
NDA 215868	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	Midazolam	Solution; Intravenous	50 mg/50 mL (1 mg/mL)	Exela Pharma.