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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 065170

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NDA 065170 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-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-one suppliers are listed for this compound. Additional details are available on the mupirocin profile page.

Summary for 065170

Tradename:	MUPIROCIN
Applicant:	Sun Pharma Canada
Ingredient:	mupirocin
Patents:	0

Pharmacology for NDA: 065170

Mechanism of Action	RNA Synthetase Inhibitors

Medical Subject Heading (MeSH) Categories for 065170

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 065170

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUPIROCIN	mupirocin	OINTMENT;TOPICAL	065170	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1076	0121-1076-00	100 TUBE in 1 CARTON (0121-1076-00) / 1 g in 1 TUBE (0121-1076-01)
MUPIROCIN	mupirocin	OINTMENT;TOPICAL	065170	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1076	0121-1076-50	50 TUBE in 1 CARTON (0121-1076-50) / 1 g in 1 TUBE (0121-1076-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	2%
Approval Date:	Sep 23, 2005	TE:	AB	RLD:	No

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