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FDA NDA · NDA020676

VAGISTAT-1

Sponsor: COMBE

APPLICATION
NDA020676
TYPE
NDA
ORIGINAL APPROVAL
1997-02-11
LATEST ACTION
2016-04-21
ROUTE
VAGINAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Over-the-counter

Products

VAGISTAT-1 · ReferenceOver-the-counter
TIOCONAZOLE 6.5% · OINTMENT · VAGINAL

Approval history

2016-04-21Manufacturing (CMC) · Supplement 11 · standardAP
2009-09-15Labeling · Supplement 9 · standard — Label ↗AP
2001-12-12Manufacturing (CMC) · Supplement 5 · standardAP
2001-08-09Labeling · Supplement 4 · standard — Label ↗AP
2001-04-24Labeling · Supplement 3 · standardAP
2001-04-24Labeling · Supplement 1 · standardAP
1998-09-23Manufacturing (CMC) · Supplement 2 · standardAP
1997-02-11Type 8 - Partial Rx to OTC Switch · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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