APPLICATION
ANDA089590
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-19
LATEST ACTION
2002-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFASALAZINEDiscontinued
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
2002-05-15Manufacturing (CMC) · Supplement 27AP
2001-11-21Manufacturing (CMC) · Supplement 26AP
2001-08-21Labeling · Supplement 25AP
2001-08-21Manufacturing (CMC) · Supplement 23AP
2001-08-21Manufacturing (CMC) · Supplement 24AP
2001-04-18Manufacturing (CMC) · Supplement 22AP
2001-02-05Manufacturing (CMC) · Supplement 21AP
2000-05-16Manufacturing (CMC) · Supplement 19AP
2000-05-16Manufacturing (CMC) · Supplement 18AP
2000-03-24Labeling · Supplement 20AP
1998-12-23Manufacturing (CMC) · Supplement 14AP
1998-11-23Manufacturing (CMC) · Supplement 17AP
1998-11-23Manufacturing (CMC) · Supplement 16AP
1998-03-25Labeling · Supplement 13AP
1997-12-05Manufacturing (CMC) · Supplement 12AP
1997-02-24Manufacturing (CMC) · Supplement 11AP
1995-10-06Manufacturing (CMC) · Supplement 10AP
1995-06-22Manufacturing (CMC) · Supplement 9AP
1994-01-12Manufacturing (CMC) · Supplement 7AP
1991-12-11Manufacturing (CMC) · Supplement 1AP
1991-05-21Labeling · Supplement 6AP
1991-04-03Manufacturing (CMC) · Supplement 4AP
1991-02-11Labeling · Supplement 3AP
1990-09-26Labeling · Supplement 2AP
1987-10-19OriginalAP
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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