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Generated: August 21, 2018

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Details for New Drug Application (NDA): 076624

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NDA 076624 describes MOMETASONE FUROATE, which is a drug marketed by Fougera Pharms, G And W Labs, Glenmark Generics, Taro, Tolmar, Perrigo Israel, Perrigo New York, Torrent Pharms Ltd, Amneal Pharms, and Apotex Inc, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the MOMETASONE FUROATE profile page.

The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are twenty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 076624
Tradename:MOMETASONE FUROATE
Applicant:Taro
Ingredient:mometasone furoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076624
Medical Subject Heading (MeSH) Categories for 076624
Suppliers and Packaging for NDA: 076624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOMETASONE FUROATE mometasone furoate OINTMENT;TOPICAL 076624 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1311 N 51672-1311-1
MOMETASONE FUROATE mometasone furoate OINTMENT;TOPICAL 076624 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1311 N 51672-1311-6

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Dec 3, 2004TE:RLD:No

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