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Serving 500+ biopharmaceutical companies globally:

Colorcon
Merck
QuintilesIMS
Fish and Richardson
Cerilliant
Accenture
US Army
Moodys
Citi
Cantor Fitzgerald

Generated: August 22, 2017

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Details for New Drug Application (NDA): 201764

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NDA 201764 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: 201764

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: 201764

Suppliers and Packaging for NDA: 201764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
OIL;TOPICAL 201764 ANDA AvKARE, Inc. 42291-285 42291-285-04 1 BOTTLE in 1 CARTON (42291-285-04) > 118.28 mL in 1 BOTTLE
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
OIL;TOPICAL 201764 ANDA Physicians Total Care, Inc. 54868-6383 54868-6383-0 1 BOTTLE in 1 CARTON (54868-6383-0) > 118.28 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:Oct 17, 2011TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Cerilliant
Queensland Health
Baxter
Daiichi Sankyo
UBS
Dow
US Army
Covington
Julphar

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