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Details for New Drug Application (NDA): 065192

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NDA 065192 describes MUPIROCIN, which is a drug marketed by Perrigo New York, Taro, Glenmark Pharms, Teva, Glenmark Generics, and Fougera Pharms, and is included in six NDAs. It is available from twenty-six suppliers. Additional details are available on the MUPIROCIN profile page.

The generic ingredient in MUPIROCIN is mupirocin calcium. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mupirocin calcium profile page.

Summary for NDA: 065192

Tradename:
MUPIROCIN
Applicant:
Fougera Pharms
Ingredient:
mupirocin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065192

Mechanism of ActionRNA Synthetase Inhibitors

Suppliers and Packaging for NDA: 065192

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUPIROCIN
mupirocin
OINTMENT;TOPICAL 065192 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0352 0168-0352-22 22 g in 1 TUBE (0168-0352-22)
MUPIROCIN
mupirocin
OINTMENT;TOPICAL 065192 ANDA Rebel Distributors Corp. 21695-188 21695-188-22 22 g in 1 TUBE (21695-188-22)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength2%
Approval Date:Nov 30, 2005TE:ABRLD:No


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