APPLICATION
ANDA088718
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-19
LATEST ACTION
2001-08-30
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
SULFANILAMIDEDiscontinued
SULFANILAMIDE 15% · CREAM · VAGINAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 33AP
2000-07-07Manufacturing (CMC) · Supplement 32AP
1996-09-13Manufacturing (CMC) · Supplement 28AP
1996-02-22Manufacturing (CMC) · Supplement 24AP
1994-11-02Manufacturing (CMC) · Supplement 26AP
1994-11-02Manufacturing (CMC) · Supplement 27AP
1994-11-02Manufacturing (CMC) · Supplement 25AP
1994-01-26Manufacturing (CMC) · Supplement 22AP
1994-01-26Manufacturing (CMC) · Supplement 23AP
1994-01-26Manufacturing (CMC) · Supplement 21AP
1993-10-21Manufacturing (CMC) · Supplement 18AP
1993-10-21Manufacturing (CMC) · Supplement 16AP
1993-10-21Manufacturing (CMC) · Supplement 14AP
1993-10-21Manufacturing (CMC) · Supplement 20AP
1993-10-21Manufacturing (CMC) · Supplement 19AP
1993-10-21Manufacturing (CMC) · Supplement 15AP
1993-08-31Manufacturing (CMC) · Supplement 17AP
1993-05-25Manufacturing (CMC) · Supplement 12AP
1993-05-25Manufacturing (CMC) · Supplement 13AP
1993-05-25Manufacturing (CMC) · Supplement 11AP
1993-05-21Manufacturing (CMC) · Supplement 8AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
1991-02-05Labeling · Supplement 7AP
1990-02-06Labeling · Supplement 6AP
1990-02-06Labeling · Supplement 4AP
1989-09-05Labeling · Supplement 5AP
1989-06-21Manufacturing (CMC) · Supplement 3AP
1985-09-19OriginalAP
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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