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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091306

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NDA 091306 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Actavis Labs Ut Inc, Bausch And Lomb, G And W Labs Inc, Gavis Pharms Llc, and Morton Grove, 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-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 091306

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091306

Medical Subject Heading (MeSH) Categories for 091306

Suppliers and Packaging for NDA: 091306

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 091306 ANDA AvKARE, Inc. 42291-283 42291-283-20 1 BOTTLE in 1 CARTON (42291-283-20) > 20 mL in 1 BOTTLE
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 091306 ANDA Amneal Pharmaceuticals, LLC 65162-702 65162-702-94 1 BOTTLE in 1 CARTON (65162-702-94) > 20 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL/DROPS;OTICStrength0.01%
Approval Date:Oct 17, 2011TE:ATRLD:No


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