APPLICATION
NDA050591
TYPE
NDA
ORIGINAL APPROVAL
1987-12-31
LATEST ACTION
2017-05-08
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
BACTROBAN · ReferenceDiscontinued
MUPIROCIN 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
2001-11-09Manufacturing (CMC) · Supplement 26 · standardAP
2001-09-21Manufacturing (CMC) · Supplement 25 · standardAP
2000-09-12Manufacturing (CMC) · Supplement 24 · standardAP
1999-05-19Manufacturing (CMC) · Supplement 23 · standardAP
1997-12-03Manufacturing (CMC) · Supplement 21 · standardAP
1996-12-24Manufacturing (CMC) · Supplement 20 · standardAP
1996-06-06Manufacturing (CMC) · Supplement 19 · standardAP
1996-02-21Labeling · Supplement 15AP
1994-03-24Manufacturing (CMC) · Supplement 16 · standardAP
1994-03-24Manufacturing (CMC) · Supplement 17 · standardAP
1993-11-02Manufacturing (CMC) · Supplement 18 · standardAP
1991-09-30Labeling · Supplement 12AP
1991-04-15Labeling · Supplement 9AP
1991-04-15Labeling · Supplement 11AP
1991-04-15Labeling · Supplement 10AP
1991-04-15Labeling · Supplement 13AP
1987-12-31Type 1 - New Molecular Entity · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.