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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 201587


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NDA 201587 describes MUPIROCIN, which is a drug marketed by Alembic, Amneal, Encube, Glenmark Pharms Inc, Padagis Israel, Taro, Fougera Pharms, Glenmark Pharms, and Teva, and is included in eleven NDAs. It is available from twenty-five suppliers. Additional details are available on the MUPIROCIN profile page.

The generic ingredient in MUPIROCIN is mupirocin. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mupirocin profile page.
Summary for 201587
Tradename:MUPIROCIN
Applicant:Glenmark Pharms Inc
Ingredient:mupirocin calcium
Patents:0
Pharmacology for NDA: 201587
Mechanism of ActionRNA Synthetase Inhibitors
Suppliers and Packaging for NDA: 201587
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUPIROCIN mupirocin calcium CREAM;TOPICAL 201587 ANDA Glenmark Pharmaceuticals Inc., USA 68462-560 68462-560-47 1 BOTTLE in 1 CARTON (68462-560-47) / 42.5 g in 1 BOTTLE
MUPIROCIN mupirocin calcium CREAM;TOPICAL 201587 ANDA Glenmark Pharmaceuticals Inc., USA 68462-564 68462-564-17 15 g in 1 TUBE (68462-564-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 2% BASE
Approval Date:Jan 24, 2013TE:ABRLD:No

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