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Generated: January 15, 2019

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Details for New Drug Application (NDA): 086413

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NDA 086413 describes TRIAMCINOLONE ACETONIDE, which is a drug marketed by Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Fougera Pharms, G And W Labs, Glenmark Pharms Ltd, Lannett Co Inc, Lupin Atlantis, Macleods Pharms Ltd, Morton Grove, Mylan Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Topiderm, Amneal Pharms Co, Parnell, Sandoz Inc, Teva Pharms Usa, Watson Labs, Akorn, G And W Labs Inc, Wockhardt Bio Ag, Glenmark Pharms, Novel Labs Inc, Lyne, Perrigo Israel, Perrigo Uk Finco, Rising Pharms, and Cmp Pharma Inc, and is included in seventy-nine NDAs. It is available from sixty-four suppliers. Additional details are available on the TRIAMCINOLONE ACETONIDE profile page.

The generic ingredient in TRIAMCINOLONE ACETONIDE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 086413
Tradename:TRIAMCINOLONE ACETONIDE
Applicant:Perrigo New York
Ingredient:triamcinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 086413
Medical Subject Heading (MeSH) Categories for 086413
Suppliers and Packaging for NDA: 086413
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMCINOLONE ACETONIDE triamcinolone acetonide CREAM;TOPICAL 086413 ANDA Perrigo New York Inc 45802-063 45802-063-05 454 g in 1 JAR (45802-063-05)
TRIAMCINOLONE ACETONIDE triamcinolone acetonide CREAM;TOPICAL 086413 ANDA Perrigo New York Inc 45802-063 45802-063-35 1 TUBE in 1 CARTON (45802-063-35) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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