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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206075

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NDA 206075 describes CLOBETASOL PROPIONATE, which is a drug marketed by Ingenus Pharms Llc, Perrigo Israel, 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, Chemo Research Sl, 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-one 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 thirteen 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 206075
Tradename:CLOBETASOL PROPIONATE
Applicant:Novel Labs Inc
Ingredient:clobetasol propionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 206075
Medical Subject Heading (MeSH) Categories for 206075
Suppliers and Packaging for NDA: 206075
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 206075 ANDA Novel Laboratories, Inc. 40032-028 N 40032-028-60
CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 206075 ANDA Lupin Pharmaceuticals,Inc. 43386-028 N 43386-028-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Nov 23, 2015TE:ATRLD:No

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