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Argus Health
US Department of Justice
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Merck
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Generated: February 22, 2018

DrugPatentWatch Database Preview

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, Fougera Pharms Inc, G And W Labs Inc, Lupin Ltd, Mylan Pharms Inc, Taro, Teva Pharms Usa, Fougera Pharms, Perrigo Co, Teligent Pharma Inc, Actavis Mid Atlantic, Glenmark Pharms, Zydus Pharms Usa Inc, Hi-tech Pharmacal, Macleods Pharms Ltd, Novel Labs Inc, Tolmar, Wockhardt Bio Ag, Akorn, Paddock Llc, and Novast Labs Ltd, and is included in forty-two NDAs. It is available from thirty-two suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are thirteen drug master file entries for this compound. Thirty-nine 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 N 0378-8190-30
CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057 ANDA Mylan Pharmaceuticals Inc. 0378-8190 N 0378-8190-15

Profile for product number 001

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

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QuintilesIMS
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