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Generated: September 20, 2018

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Details for New Drug Application (NDA): 075057

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NDA 075057 describes CLOBETASOL PROPIONATE, which is a drug marketed by Ingenus Pharms Llc, Perrigo Israel, Chemo Research Sl, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms, Lupin Ltd, Mylan Pharms Inc, Taro, Teligent Pharma Inc, Teva Pharms Usa, Fougera Pharms, Perrigo Co, Actavis Mid Atlantic, Amneal Pharms Llc, Novel Labs Inc, Zydus Pharms Usa Inc, Hi-tech Pharmacal, Glenmark Pharms Ltd, Macleods Pharms Ltd, Tolmar, Wockhardt Bio Ag, Akorn, Apotex Inc, Paddock Llc, and Novast Labs Ltd, and is included in fifty-three NDAs. It is available from thirty-six 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. Forty-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075057
Tradename:CLOBETASOL PROPIONATE
Applicant:Mylan Pharms Inc
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075057
Medical Subject Heading (MeSH) Categories for 075057
Suppliers and Packaging for NDA: 075057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057 ANDA Mylan Pharmaceuticals Inc. 0378-8190 0378-8190-15 1 TUBE in 1 CARTON (0378-8190-15) > 15 g in 1 TUBE
CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057 ANDA Mylan Pharmaceuticals Inc. 0378-8190 0378-8190-30 1 TUBE in 1 CARTON (0378-8190-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Aug 12, 1998TE:ABRLD:No

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