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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 211450

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NDA 211450 describes CLOBETASOL PROPIONATE, which is a drug marketed by Aleor Dermaceuticals, Glenmark Pharms Ltd, Ingenus Pharms Llc, Padagis Israel, Taro, Amneal, Aurobindo Pharma Usa, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Akorn, Cadila, Novel Labs Inc, Taro Pharms, Macleods Pharms Ltd, Prinston Inc, Saptalis Pharms, Solaris Pharma Corp, Wockhardt Bio Ag, Apotex, and Ani Pharms, and is included in seventy-eight NDAs. It is available from forty-two suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 211450
Applicant:Glenmark Pharms Ltd
Ingredient:clobetasol propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 211450
Medical Subject Heading (MeSH) Categories for 211450
Suppliers and Packaging for NDA: 211450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM;TOPICAL 211450 ANDA Glenmark Pharmaceuticals Inc., USA 68462-625 68462-625-27 50 g in 1 CAN (68462-625-27)
CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM;TOPICAL 211450 ANDA Glenmark Pharmaceuticals Inc., USA 68462-625 68462-625-94 100 g in 1 CAN (68462-625-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:Sep 9, 2019TE:AB2RLD:No

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