Details for New Drug Application (NDA): 209699

NDA 209699 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 209699

Tradename:	FLUOCINONIDE
Applicant:	Encube Ethicals
Ingredient:	fluocinonide
Patents:	0

Pharmacology for NDA: 209699

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 209699

Anti-Allergic Agents

Anti-Inflammatory Agents

Glucocorticoids

Suppliers and Packaging for NDA: 209699

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	209699	ANDA	Encube Ethicals Private Limited	21922-001	21922-001-01	1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE
FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	209699	ANDA	Bryant Ranch Prepack	63629-9583	63629-9583-1	1 BOTTLE in 1 CARTON (63629-9583-1) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Nov 29, 2018	TE:	AT	RLD:	No

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