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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Chinese Patent Office
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209336

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NDA 209336 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Taro, Akorn, 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 Pharms Inc, Lyne, and Actavis Labs Ut Inc, and is included in forty-six NDAs. It is available from fourteen 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-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for NDA: 209336

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 209336

Suppliers and Packaging for NDA: 209336

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluocinolone acetonide
OIL;TOPICAL 209336 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1357 51672-1357-8 1 BOTTLE in 1 CARTON (51672-1357-8) > 118.28 mL in 1 BOTTLE

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
US Department of Justice
Chinese Patent Office
Cantor Fitzgerald
Fish and Richardson

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