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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065085


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NDA 065085 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 065085
Tradename:MUPIROCIN
Applicant:Teva
Ingredient:mupirocin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065085
Mechanism of ActionRNA Synthetase Inhibitors
Medical Subject Heading (MeSH) Categories for 065085
Suppliers and Packaging for NDA: 065085
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUPIROCIN mupirocin OINTMENT;TOPICAL 065085 ANDA Teva Pharmaceuticals USA, Inc. 0093-1010 0093-1010-42 1 TUBE in 1 CARTON (0093-1010-42) / 22 g in 1 TUBE
MUPIROCIN mupirocin OINTMENT;TOPICAL 065085 ANDA Medsource Pharmaceuticals 45865-722 45865-722-01 1 TUBE in 1 CARTON (45865-722-01) / 22 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength2%
Approval Date:Nov 7, 2003TE:ABRLD:No

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