APPLICATION
ANDA085828
TYPE
ANDA
ORIGINAL APPROVAL
1977-10-21
LATEST ACTION
2025-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULFASALAZINEPrescription
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
2025-03-04Labeling · Supplement 44 · standardAP
2022-07-26Labeling · Supplement 42 · standardAP
2022-07-26Labeling · Supplement 40 · standardAP
2015-02-25Labeling · Supplement 37 · standardAP
2015-02-25Labeling · Supplement 38 · standardAP
2013-08-21Labeling · Supplement 36 · standardAP
2010-12-31Labeling · Supplement 35AP
2003-05-05Labeling · Supplement 34AP
1998-10-27Labeling · Supplement 33AP
1998-04-23Labeling · Supplement 32AP
1997-10-08Manufacturing (CMC) · Supplement 30AP
1997-10-08Manufacturing (CMC) · Supplement 31AP
1997-05-27Manufacturing (CMC) · Supplement 29AP
1993-03-31Labeling · Supplement 28AP
1991-07-22Labeling · Supplement 27AP
1991-05-21Labeling · Supplement 26AP
1988-08-15Manufacturing (CMC) · Supplement 24AP
1988-08-15Manufacturing (CMC) · Supplement 22AP
1988-08-15Manufacturing (CMC) · Supplement 23AP
1988-08-15Manufacturing (CMC) · Supplement 21AP
1988-03-04Manufacturing (CMC) · Supplement 19AP
1987-03-20Manufacturing (CMC) · Supplement 16AP
1987-03-20Manufacturing (CMC) · Supplement 17AP
1987-03-20Manufacturing (CMC) · Supplement 15AP
1986-04-15Manufacturing (CMC) · Supplement 14AP
1983-07-22Manufacturing (CMC) · Supplement 8AP
1983-05-13Manufacturing (CMC) · Supplement 6AP
1983-05-13Manufacturing (CMC) · Supplement 7AP
1977-10-21OriginalAP
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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