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Generated: April 27, 2017

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Details for New Drug Application (NDA): 050703

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NDA 050703 describes BACTROBAN, which is a drug marketed by Glaxosmithkline and is included in three NDAs. It is available from six suppliers. Additional details are available on the BACTROBAN profile page.

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

Summary for NDA: 050703

Therapeutic Class:Antibacterials

Pharmacology for NDA: 050703

Mechanism of ActionRNA Synthetase Inhibitors

Suppliers and Packaging for NDA: 050703

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mupirocin calcium
OINTMENT;NASAL 050703 NDA GlaxoSmithKline LLC 0029-1526 0029-1526-11 10 CARTON in 1 PACKAGE (0029-1526-11) > 1 TUBE in 1 CARTON (0029-1526-03) > 1 g in 1 TUBE
mupirocin calcium
OINTMENT;NASAL 050703 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-468 35356-468-01 10 TUBE in 1 PACKAGE (35356-468-01) > 1 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;NASALStrengthEQ 2% BASE
Approval Date:Sep 18, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 050703

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
mupirocin calcium
OINTMENT;NASAL050703-001Sep 18, 19955,569,672► Subscribe
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