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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076973


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NDA 076973 describes ALCLOMETASONE DIPROPIONATE, which is a drug marketed by Fougera Pharms, Glenmark Generics, and Taro, and is included in six NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.
Summary for 076973
Tradename:ALCLOMETASONE DIPROPIONATE
Applicant:Fougera Pharms
Ingredient:alclometasone dipropionate
Patents:0
Pharmacology for NDA: 076973
Suppliers and Packaging for NDA: 076973
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 076973 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0263 0168-0263-15 15 g in 1 TUBE (0168-0263-15)
ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 076973 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0263 0168-0263-45 45 g in 1 TUBE (0168-0263-45)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jul 12, 2005TE:ABRLD:No

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