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FDA ANDA · ANDA073508

MICONAZOLE NITRATE

Sponsor: ACTAVIS PHARMA

APPLICATION
ANDA073508
TYPE
ANDA
ORIGINAL APPROVAL
1993-11-19
LATEST ACTION
2002-07-09
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription

Products

MICONAZOLE NITRATEPrescription
MICONAZOLE NITRATE 200MG · SUPPOSITORY · VAGINAL

Approval history

2002-07-09Manufacturing (CMC) · Supplement 15AP
2002-01-08Manufacturing (CMC) · Supplement 14AP
2000-12-29Manufacturing (CMC) · Supplement 13AP
1998-01-09Manufacturing (CMC) · Supplement 12AP
1996-10-11Manufacturing (CMC) · Supplement 7AP
1996-07-24Manufacturing (CMC) · Supplement 6AP
1996-07-24Manufacturing (CMC) · Supplement 4AP
1996-07-24Manufacturing (CMC) · Supplement 9AP
1996-07-24Manufacturing (CMC) · Supplement 5AP
1996-06-28Manufacturing (CMC) · Supplement 8AP
1995-05-15Manufacturing (CMC) · Supplement 2AP
1995-01-30Manufacturing (CMC) · Supplement 1AP
1993-11-19OriginalAP
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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