← FDA DRUG APPROVALS

FDA NDA · NDA019964

TERAZOL 3

Sponsor: JANSSEN PHARMS

APPLICATION
NDA019964
TYPE
NDA
ORIGINAL APPROVAL
1991-02-21
LATEST ACTION
2014-07-23
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

TERAZOL 3 · ReferenceDiscontinued
TERCONAZOLE 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · VAGINAL

Approval history

2014-07-23Labeling · Supplement 32 · standard — Letter ↗AP
2013-09-26Labeling · Supplement 30 · standard — Letter ↗AP
2013-07-23Manufacturing (CMC) · Supplement 31 · standardAP
2004-06-30Labeling · Supplement 21 · standard — Label ↗AP
2003-09-24Labeling · Supplement 20 · standard — Letter ↗AP
2003-03-11Labeling · Supplement 11 · standard — Label ↗AP
2003-03-11Labeling · Supplement 14 · standard — Letter ↗AP
2002-10-04Manufacturing (CMC) · Supplement 17 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 16 · standardAP
2001-12-10Manufacturing (CMC) · Supplement 15 · standardAP
2001-09-21Manufacturing (CMC) · Supplement 13 · standardAP
2001-03-13Manufacturing (CMC) · Supplement 12 · standardAP
1999-10-28Manufacturing (CMC) · Supplement 8 · standardAP
1999-10-08Manufacturing (CMC) · Supplement 9 · standardAP
1999-10-08Manufacturing (CMC) · Supplement 10 · standardAP
1998-10-07Manufacturing (CMC) · Supplement 7 · standardAP
1997-07-28Labeling · Supplement 6 · standardAP
1994-10-17Manufacturing (CMC) · Supplement 5 · standardAP
1993-02-09Manufacturing (CMC) · Supplement 4 · standardAP
1992-09-25Manufacturing (CMC) · Supplement 2 · standardAP
1992-03-11Manufacturing (CMC) · Supplement 1 · standardAP
1991-02-21Type 5 - New Formulation or New Manufacturer · 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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