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FDA ANDA · ANDA072640

CLOTRIMAZOLE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA072640
TYPE
ANDA
ORIGINAL APPROVAL
1993-08-31
LATEST ACTION
2009-08-20
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

CLOTRIMAZOLEPrescription
CLOTRIMAZOLE 1% · CREAM · TOPICAL

Approval history

2009-08-20Labeling · Supplement 31AP
2002-11-04Manufacturing (CMC) · Supplement 26AP
2001-10-15Manufacturing (CMC) · Supplement 25AP
2001-10-15Manufacturing (CMC) · Supplement 24AP
2001-01-24Manufacturing (CMC) · Supplement 23AP
2001-01-24Manufacturing (CMC) · Supplement 21AP
2001-01-24Manufacturing (CMC) · Supplement 22AP
2001-01-24Manufacturing (CMC) · Supplement 20AP
2000-11-20Manufacturing (CMC) · Supplement 19AP
2000-03-14Manufacturing (CMC) · Supplement 18AP
1999-08-24Labeling · Supplement 17AP
1999-06-23Manufacturing (CMC) · Supplement 15AP
1999-06-23Labeling · Supplement 16AP
1999-06-23Manufacturing (CMC) · Supplement 14AP
1998-01-29Manufacturing (CMC) · Supplement 13AP
1997-12-08Manufacturing (CMC) · Supplement 12AP
1997-01-09Manufacturing (CMC) · Supplement 7AP
1997-01-07Manufacturing (CMC) · Supplement 9AP
1996-09-17Manufacturing (CMC) · Supplement 8AP
1996-06-24Manufacturing (CMC) · Supplement 6AP
1995-08-01Manufacturing (CMC) · Supplement 5AP
1995-04-28Manufacturing (CMC) · Supplement 4AP
1994-07-14Manufacturing (CMC) · Supplement 2AP
1994-06-15Manufacturing (CMC) · Supplement 1AP
1993-08-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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