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FDA ANDA · ANDA074414

MICONAZOLE NITRATE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA074414
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-30
LATEST ACTION
2002-06-04
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued

Products

MICONAZOLE NITRATEDiscontinued
MICONAZOLE NITRATE 100MG · SUPPOSITORY · VAGINAL

Approval history

2002-06-04Manufacturing (CMC) · Supplement 3AP
2002-05-31Manufacturing (CMC) · Supplement 2AP
1997-10-21Manufacturing (CMC) · Supplement 1AP
1997-04-30OriginalReviewAP
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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