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Details for New Drug Application (NDA): 202705

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NDA 202705 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Taro, Versapharm Inc, Pharmafair, Identi Pharms Inc, Perrigo New York, Morton Grove, Gavis Pharms Llc, G And W Labs, G And W Labs Inc, Usl Pharma, Pharmaderm, Perrigo Israel, Alpharma Us Pharms, Bausch And Lomb, Fougera, Lyne, and Actavis Labs Ut Inc, and is included in forty-five NDAs. It is available from thirteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

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

Summary for NDA: 202705

Pharmacology for NDA: 202705

Suppliers and Packaging for NDA: 202705

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
OIL/DROPS;OTIC 202705 ANDA VersaPharm Incorporated 61748-250 61748-250-20 1 BOTTLE in 1 CARTON (61748-250-20) > 20 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL/DROPS;OTICStrength0.01%
Approval Date:Sep 9, 2016TE:ATRLD:No


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