APPLICATION
NDA007073
TYPE
NDA
ORIGINAL APPROVAL
1950-06-20
LATEST ACTION
2022-11-16
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
1993-06-09Manufacturing (CMC) · Supplement 86 · priorityAP
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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