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Last Updated: November 5, 2024

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 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-one suppliers are listed for this compound. Additional details are available on the mupirocin profile page.
Summary for 207116
Tradename:MUPIROCIN
Applicant:Taro
Ingredient:mupirocin calcium
Patents:0
Pharmacology for NDA: 207116
Mechanism of ActionRNA 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:RXDosage:CREAM;TOPICALStrengthEQ 2% BASE
Approval Date:Apr 27, 2020TE:ABRLD:No

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