APPLICATION
ANDA087197
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-02
LATEST ACTION
1992-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFASALAZINEDiscontinued
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
1992-10-06Labeling · Supplement 13AP
1991-08-12Manufacturing (CMC) · Supplement 12AP
1991-08-07Manufacturing (CMC) · Supplement 10AP
1991-01-28Manufacturing (CMC) · Supplement 11AP
1984-05-03Manufacturing (CMC) · Supplement 9AP
1983-04-27Manufacturing (CMC) · Supplement 7AP
1981-04-02OriginalAP
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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