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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202368


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NDA 202368 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Akorn, Amneal, Lyne, Padagis Israel, Quagen, Tasman Pharma, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-five NDAs. It is available from fifteen 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-five suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 202368
Tradename:FLUOCINOLONE ACETONIDE
Applicant:Taro
Ingredient:fluocinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202368
Medical Subject Heading (MeSH) Categories for 202368
Suppliers and Packaging for NDA: 202368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 202368 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1356 51672-1356-8 1 BOTTLE in 1 CARTON (51672-1356-8) / 118.28 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:May 19, 2016TE:ATRLD:No

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