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Generated: May 27, 2017

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Details for New Drug Application (NDA): 076499

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NDA 076499 describes MOMETASONE FUROATE, which is a drug marketed by G And W Labs, Glenmark Generics, Fougera Pharms, Taro, Apotex Inc, Perrigo New York, Perrigo Israel, Tolmar, and Amneal Pharms, and is included in nineteen NDAs. It is available from eighteen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NDA: 076499

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076499

Suppliers and Packaging for NDA: 076499

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mometasone furoate
LOTION;TOPICAL 076499 ANDA Impax Generics 0115-1471 0115-1471-54 1 BOTTLE in 1 CARTON (0115-1471-54) > 27.5 g in 1 BOTTLE
mometasone furoate
LOTION;TOPICAL 076499 ANDA Impax Generics 0115-1471 0115-1471-55 1 BOTTLE in 1 CARTON (0115-1471-55) > 55 g in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.1%
Approval Date:Nov 21, 2007TE:ABRLD:No

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