Last Updated: November 12, 2026

Details for New Drug Application (NDA): 207116

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NDA 207116 describes MUPIROCIN, which is a drug marketed by Alembic, Amneal, Encube, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Fougera Pharms, Teva, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the MUPIROCIN profile page.

The generic ingredient in MUPIROCIN is mupirocin. There are two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mupirocin profile page.

Summary for 207116

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

Pharmacology for NDA: 207116

Mechanism of Action	RNA Synthetase Inhibitors

Suppliers and Packaging for NDA: 207116

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	207116	ANDA	NORTHSTAR RX LLC	16714-055	16714-055-01	1 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBE
MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	207116	ANDA	NORTHSTAR RX LLC	16714-055	16714-055-02	1 TUBE in 1 CARTON (16714-055-02) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 2% BASE
Approval Date:	Apr 27, 2020	TE:	AB	RLD:	No

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