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FDA NDA · NDA019881

BUTOCONAZOLE NITRATE

Sponsor: PADAGIS US

APPLICATION
NDA019881
TYPE
NDA
ORIGINAL APPROVAL
1997-02-07
LATEST ACTION
2012-08-10
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

BUTOCONAZOLE NITRATEDiscontinued
BUTOCONAZOLE NITRATE 2% · CREAM · VAGINAL

Approval history

2012-08-10Manufacturing (CMC) · Supplement 18 · standardAP
2003-07-24Labeling · Supplement 9 · standard — Letter ↗AP
2003-04-30Labeling · Supplement 2 · standard — Label ↗AP
2002-08-02Manufacturing (CMC) · Supplement 8 · standardAP
2000-09-28Manufacturing (CMC) · Supplement 6 · standardAP
2000-05-01Manufacturing (CMC) · Supplement 5 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 4 · standardAP
1997-02-07Type 3 - New Dosage Form · Original · standardAP
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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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