← FDA DRUG APPROVALS

FDA NDA · NDA020526

GYNE-LOTRIMIN 3 COMBINATION PACK

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA020526
TYPE
NDA
ORIGINAL APPROVAL
1996-07-29
LATEST ACTION
2002-01-16
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, TABLET
MARKETING STATUS
Discontinued

Products

GYNE-LOTRIMIN 3 COMBINATION PACK · ReferenceDiscontinued
CLOTRIMAZOLE 1%,200MG · CREAM, TABLET · TOPICAL, VAGINAL

Approval history

2002-01-16Manufacturing (CMC) · Supplement 7 · standardAP
2001-05-16Manufacturing (CMC) · Supplement 5 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 6 · standardAP
2000-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 2 · standardAP
1997-02-27Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-29Type 8 - Partial Rx to OTC Switch · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →