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Last Updated: December 22, 2024

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, Chartwell Rx, Cosette, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Micro Labs, Morton Grove, Norvium Bioscience, Padagis Us, Pharmaderm, Pharmafair, Strides Pharma, Taro, Topiderm, Amneal, Eugia Pharma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Epic Pharma Llc, Pai Holdings Pharm, Quagen, Wockhardt Bio Ag, Aurobindo Pharma Ltd, Cintex Svcs, Glenmark Speclt, Padagis Israel, Rising, Sciegen Pharms Inc, Apotex, and Perrigo Pharma Intl, and is included in ninety-three NDAs. It is available from sixty-one 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. Seventy-three suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 086413
Tradename:TRIAMCINOLONE ACETONIDE
Applicant:Padagis Us
Ingredient:triamcinolone acetonide
Patents:0
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 Padagis Israel Pharmaceuticals Ltd 45802-063 45802-063-05 454 g in 1 JAR (45802-063-05)
TRIAMCINOLONE ACETONIDE triamcinolone acetonide CREAM;TOPICAL 086413 ANDA Padagis Israel Pharmaceuticals Ltd 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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