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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201759

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NDA 201759 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 201759
Pharmacology for NDA: 201759
Medical Subject Heading (MeSH) Categories for 201759
Suppliers and Packaging for NDA: 201759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 201759 ANDA AvKARE, Inc. 42291-284 42291-284-04 1 BOTTLE in 1 CARTON (42291-284-04) > 118.28 mL in 1 BOTTLE
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 201759 ANDA Physicians Total Care, Inc. 54868-6347 54868-6347-0 1 BOTTLE in 1 CARTON (54868-6347-0) > 118.28 mL in 1 BOTTLE

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Healthtrust
Merck
Accenture
Mallinckrodt
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Argus Health
Farmers Insurance
Dow
Teva

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