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Last Updated: December 15, 2025

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, Sun Pharma Canada, Fougera Pharms, Glenmark Pharms, and Teva, and is included in twelve NDAs. It is available from twenty-four 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

Pharmacology for NDA: 065085

Mechanism of Action	RNA Synthetase Inhibitors

Medical Subject Heading (MeSH) Categories for 065085

Anti-Bacterial Agents
Protein Synthesis Inhibitors

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	Proficient Rx LP	63187-525	63187-525-22	1 TUBE in 1 CARTON (63187-525-22) / 22 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	2%
Approval Date:	Nov 7, 2003	TE:	AB	RLD:	No

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