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Details for New Drug Application (NDA): 078571

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NDA 078571 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-eight 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: 078571

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

Pharmacology for NDA: 078571

Suppliers and Packaging for NDA: 078571

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mometasone furoate
OINTMENT;TOPICAL 078571 ANDA Glenmark Pharmaceuticals Inc., USA 68462-225 68462-225-17 15 g in 1 TUBE (68462-225-17)
mometasone furoate
OINTMENT;TOPICAL 078571 ANDA Glenmark Pharmaceuticals Inc., USA 68462-225 68462-225-55 45 g in 1 TUBE (68462-225-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:May 28, 2008TE:ABRLD:No

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