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FDA NDA · NDA021143

CLOTRIMAZOLE

Sponsor: SUN PHARMA CANADA

APPLICATION
NDA021143
TYPE
NDA
ORIGINAL APPROVAL
2000-04-12
LATEST ACTION
2016-08-25
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

TRIVAGIZOLE 3Over-the-counter
CLOTRIMAZOLE 2% · CREAM · VAGINAL

Approval history

2016-08-25Labeling · Supplement 12 · standard — Letter ↗AP
2014-05-15Manufacturing (CMC) · Supplement 11 · standardAP
2002-12-10Manufacturing (CMC) · Supplement 5 · standardAP
2002-11-08Manufacturing (CMC) · Supplement 4 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 3 · standardAP
2001-01-10Manufacturing (CMC) · Supplement 2 · standardAP
2000-10-18Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-12Type 3 - New Dosage Form · Original · standard — Review ↗AP
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.

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