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Last Updated: May 17, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211191

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NDA 211191 describes CLOBETASOL PROPIONATE, which is a drug marketed by Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Aleor Dermaceuticals, Amneal, Cosette, Encube, Fougera Pharms Inc, Glasshouse Pharms, Glenmark Pharms, Lupin Ltd, Mylan, Rising, Teligent, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Perrigo Co, Actavis Mid Atlantic, Akorn, Cadila, Novel Labs Inc, Taro Pharms, Macleods Pharms Ltd, Prinston Inc, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Apotex, Paddock Llc, and Ani Pharms Inc, and is included in seventy-five NDAs. It is available from forty-four 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 211191
Tradename:CLOBETASOL PROPIONATE
Applicant:Aleor Dermaceuticals
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211191
Medical Subject Heading (MeSH) Categories for 211191
Suppliers and Packaging for NDA: 211191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 211191 ANDA Alembic Pharmaceuticals, Inc. 62332-425 62332-425-12 1 BOTTLE in 1 CARTON (62332-425-12) > 125 mL in 1 BOTTLE
CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 211191 ANDA Alembic Pharmaceuticals, Inc. 62332-425 62332-425-59 1 BOTTLE in 1 CARTON (62332-425-59) > 59 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.05%
Approval Date:Oct 2, 2019TE:ATRLD:No

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