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Serving 500+ biopharmaceutical companies globally:

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Dow
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Generated: June 27, 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 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-five 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: 091306

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

Pharmacology for NDA: 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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Serving 500+ biopharmaceutical companies globally:

Accenture
Queensland Health
Dow
Daiichi Sankyo
QuintilesIMS
UBS
Baxter
US Army
AstraZeneca
Argus Health

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