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Details for New Drug Application (NDA): 077061

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NDA 077061 describes MOMETASONE FUROATE, which is a drug marketed by G And W Labs, Glenmark Generics, Fougera Pharms, Taro, Apotex Inc, Perrigo New York, Perrigo, and Tolmar, and is included in eighteen NDAs. It is available from seventeen suppliers. Additional details are available on the MOMETASONE FUROATE profile page.

The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NDA: 077061

Tradename:
MOMETASONE FUROATE
Applicant:
Fougera Pharms
Ingredient:
mometasone furoate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077061

Suppliers and Packaging for NDA: 077061

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOMETASONE FUROATE
mometasone furoate
OINTMENT;TOPICAL 077061 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0271 0168-0271-15 15 g in 1 TUBE (0168-0271-15)
MOMETASONE FUROATE
mometasone furoate
OINTMENT;TOPICAL 077061 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0271 0168-0271-46 45 g in 1 TUBE (0168-0271-46)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Mar 28, 2005TE:ABRLD:No


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