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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 213053

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NDA 213053 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 213053

Tradename:	MUPIROCIN
Applicant:	Alembic
Ingredient:	mupirocin calcium
Patents:	0

Pharmacology for NDA: 213053

Mechanism of Action	RNA Synthetase Inhibitors

Suppliers and Packaging for NDA: 213053

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Limited	46708-624	46708-624-15	1 TUBE in 1 CARTON (46708-624-15) / 15 g in 1 TUBE
MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	213053	ANDA	Alembic Pharmaceuticals Limited	46708-624	46708-624-30	1 TUBE in 1 CARTON (46708-624-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 2% BASE
Approval Date:	Nov 16, 2021	TE:	BX	RLD:	No

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