APPLICATION
ANDA040349
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-11
LATEST ACTION
2016-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULFASALAZINEPrescription
SULFASALAZINE 500MG · TABLET · ORAL
Approval history
2016-03-25Labeling · Supplement 13 · standardAP
2016-03-25Labeling · Supplement 14 · standardAP
2013-03-22Labeling · Supplement 12 · standardAP
2011-01-20Labeling · Supplement 6AP
2007-03-16Labeling · Supplement 4AP
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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