APPLICATION
NDA020208
TYPE
NDA
ORIGINAL APPROVAL
1992-08-17
LATEST ACTION
2002-04-17
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued
Products
METROGEL-VAGINAL · ReferenceDiscontinued
METRONIDAZOLE 0.75% · GEL · VAGINAL
Approval history
2002-04-17Manufacturing (CMC) · Supplement 8 · standardAP
1997-07-28Labeling · Supplement 7 · standardAP
1997-05-16Efficacy · Supplement 6 · standardAP
1995-06-30Manufacturing (CMC) · Supplement 4 · standardAP
1995-02-07Manufacturing (CMC) · Supplement 5 · standardAP
1995-01-06Labeling · Supplement 3 · standardAP
1993-07-26Labeling · Supplement 2 · standardAP
1993-03-17Manufacturing (CMC) · Supplement 1 · standardAP
1992-08-17Type 3 - New Dosage Form · Original · standardAP
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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