APPLICATION
ANDA080197
TYPE
ANDA
ORIGINAL APPROVAL
1973-11-12
LATEST ACTION
2023-08-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULFASALAZINEPrescription
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
2023-08-24Labeling · Supplement 31 · standardAP
2023-08-24Labeling · Supplement 28 · standardAP
2023-08-24Labeling · Supplement 32 · standardAP
1997-11-21Manufacturing (CMC) · Supplement 26AP
1994-06-10Manufacturing (CMC) · Supplement 25AP
1994-04-12Labeling · Supplement 24AP
1993-05-28Manufacturing (CMC) · Supplement 23AP
1993-05-28Labeling · Supplement 22AP
1991-04-26Labeling · Supplement 21AP
1991-02-08Labeling · Supplement 20AP
1989-08-01Labeling · Supplement 19AP
1988-06-29Manufacturing (CMC) · Supplement 15AP
1988-06-29Manufacturing (CMC) · Supplement 16AP
1983-04-13Manufacturing (CMC) · Supplement 11AP
1973-11-12OriginalAP
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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