← FDA DRUG APPROVALS

FDA NDA · NDA050703

BACTROBAN

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APPLICATION
NDA050703
TYPE
NDA
ORIGINAL APPROVAL
1995-09-18
LATEST ACTION
2020-02-19
ROUTE
NASAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

BACTROBAN · ReferenceDiscontinued
MUPIROCIN CALCIUM EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · NASAL

Approval history

2020-02-19Labeling · Supplement 18 · standard — Letter ↗AP
2017-05-08Labeling · Supplement 17 · standard — Label ↗AP
2015-05-14Labeling · Supplement 16 · standard — Letter ↗AP
2014-05-22Labeling · Supplement 15 · standard — Label ↗AP
2001-11-15Manufacturing (CMC) · Supplement 8 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 7 · standardAP
2000-12-13Manufacturing (CMC) · Supplement 6 · standardAP
1999-10-06Manufacturing (CMC) · Supplement 5 · standardAP
1999-05-19Manufacturing (CMC) · Supplement 4 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 3 · standardAP
1996-04-03Manufacturing (CMC) · Supplement 2 · standardAP
1995-11-20Manufacturing (CMC) · Supplement 1 · standardAP
1995-09-18Type 2 - New Active Ingredient · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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