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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076903

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NDA 076903 describes HALOBETASOL PROPIONATE, which is a drug marketed by Fougera Pharms, G And W Labs, Perrigo Israel, Taro, G And W Labs Inc, and Teligent Pharma Inc, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the HALOBETASOL PROPIONATE profile page.

The generic ingredient in HALOBETASOL PROPIONATE is halobetasol propionate. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 076903
Pharmacology for NDA: 076903
Suppliers and Packaging for NDA: 076903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076903 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0356 N 0168-0356-15
HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076903 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0356 N 0168-0356-50

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Dec 16, 2004TE:RLD:No

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Covington
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