FDA NDA · NDA020968

MONISTAT DUAL- PAK

Sponsor: PERSONAL PRODS

APPLICATION

NDA020968

TYPE

NDA

ORIGINAL APPROVAL

1999-06-30

LATEST ACTION

2014-02-11

ROUTE

TOPICAL, VAGINAL

DOSAGE FORM

CREAM, SUPPOSITORY

MARKETING STATUS

Discontinued

Products

MONISTAT DUAL- PAKDiscontinued

MICONAZOLE NITRATE 1.2GM · CREAM, SUPPOSITORY · TOPICAL, VAGINAL

2014-02-11Manufacturing (CMC) · Supplement 5 · standardAP

2013-07-10Manufacturing (CMC) · Supplement 3 · standardAP

2013-02-06Manufacturing (CMC) · Supplement 2 · standardAP

1999-06-30Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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