FDA NDA · NDA007073
AZULFIDINE EN-TABS
sulfasalazine
Sponsor: PFIZER
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
NDA007073
TYPE
NDA
ORIGINAL APPROVAL
1950-06-20
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE, TABLET
MARKETING STATUS
Prescription
Products
AZULFIDINE EN-TABS · ReferencePrescription
SULFASALAZINE 500MG · TABLET, DELAYED RELEASE · ORAL
AZULFIDINE · ReferencePrescription
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
2015-11-20Manufacturing (CMC) · Supplement 127 · priorityAP
2002-11-12Manufacturing (CMC) · Supplement 121 · priorityAP
2001-02-05Manufacturing (CMC) · Supplement 117 · priorityAP
2000-09-26Labeling · Supplement 118 · standardAP
2000-08-18Labeling · Supplement 116 · standardAP
2000-04-25Labeling · Supplement 112 · standardAP
2000-04-24Labeling · Supplement 109 · standardAP
2000-04-18Labeling · Supplement 113 · standardAP
1999-08-13Labeling · Supplement 110 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 107 · priorityAP
1996-10-17Labeling · Supplement 102 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 105 · priorityAP
1996-06-14Manufacturing (CMC) · Supplement 103 · priorityAP
1996-06-14Manufacturing (CMC) · Supplement 101 · priorityAP
1996-03-05Manufacturing (CMC) · Supplement 104 · priorityAP
1996-02-21Manufacturing (CMC) · Supplement 99 · priorityAP
1995-09-28Manufacturing (CMC) · Supplement 97 · priorityAP
1995-05-18Manufacturing (CMC) · Supplement 106 · priorityAP
1995-03-29Manufacturing (CMC) · Supplement 100 · priorityAP
1994-12-19Manufacturing (CMC) · Supplement 98 · priorityAP
1994-06-08Manufacturing (CMC) · Supplement 93 · priorityAP
1994-06-08Manufacturing (CMC) · Supplement 92 · priorityAP
1994-06-07Manufacturing (CMC) · Supplement 85 · priorityAP
1994-01-26Manufacturing (CMC) · Supplement 87 · priorityAP
1993-11-03Labeling · Supplement 96 · standardAP
1993-11-02Labeling · Supplement 95 · standardAP
1993-10-20Manufacturing (CMC) · Supplement 94 · priorityAP
1993-10-20Manufacturing (CMC) · Supplement 84 · priorityAP
1993-08-09Manufacturing (CMC) · Supplement 88 · priorityAP
1993-08-09Manufacturing (CMC) · Supplement 89 · priorityAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →