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FDA ANDA · ANDA090480

MUPIROCIN

Sponsor: GLENMARK PHARMS

APPLICATION
ANDA090480
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-08
LATEST ACTION
2021-08-04
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

MUPIROCINPrescription
MUPIROCIN 2% · OINTMENT · TOPICAL

Approval history

2021-08-04Labeling · Supplement 6 · standardAP
2021-08-04Labeling · Supplement 5 · standardAP
2016-01-05Labeling · Supplement 4 · standardAP
2016-01-05Labeling · Supplement 2 · standardAP
2011-06-08OriginalAP
VIEW ON DRUGS@FDA ↗

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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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