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Federal Trade Commission
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012104

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NDA 012104 describes KENALOG, which is a drug marketed by Mylan Pharms Inc, Delcor Asset Corp, Ranbaxy Labs Ltd, and Apothecon, and is included in ten NDAs. It is available from one supplier. Additional details are available on the KENALOG profile page.

The generic ingredient in KENALOG is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

Summary for NDA: 012104

Suppliers and Packaging for NDA: 012104

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KENALOG
triamcinolone acetonide
SPRAY;TOPICAL 012104 NDA Ranbaxy Laboratories Inc. 10631-093 10631-093-07 100 g in 1 CAN (10631-093-07)
KENALOG
triamcinolone acetonide
SPRAY;TOPICAL 012104 NDA Ranbaxy Laboratories Inc. 10631-093 10631-093-62 63 g in 1 CAN (10631-093-62)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.147MG/GM
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
UBS
Deloitte
AstraZeneca
Accenture
Moodys
Medtronic
Cipla
Healthtrust

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