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Details for New Drug Application (NDA): 079227

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NDA 079227 describes ALCLOMETASONE DIPROPIONATE, which is a drug marketed by Glenmark Generics, Taro, and Fougera Pharms, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ALCLOMETASONE DIPROPIONATE profile page.

The generic ingredient in ALCLOMETASONE DIPROPIONATE is alclometasone dipropionate. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.

Summary for NDA: 079227

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for NDA: 079227

Suppliers and Packaging for NDA: 079227

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
alclometasone dipropionate
OINTMENT;TOPICAL 079227 ANDA Glenmark Pharmaceuticals Inc., USA 68462-299 68462-299-17 15 g in 1 TUBE (68462-299-17)
alclometasone dipropionate
OINTMENT;TOPICAL 079227 ANDA Glenmark Pharmaceuticals Inc., USA 68462-299 68462-299-47 45 g in 1 TUBE (68462-299-47)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Jul 30, 2009TE:ABRLD:No

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