APPLICATION
ANDA075568
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-13
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZATHIOPRINEPrescription
AZATHIOPRINE 50MG · TABLET · ORAL
Approval history
2026-07-16Labeling · Supplement 31 · standardAP
2019-04-23Labeling · Supplement 27 · standardAP
2015-05-29Labeling · Supplement 18 · standardAP
2011-03-23Labeling · Supplement 15AP
2008-06-28Labeling · Supplement 13AP
2007-03-06Labeling · Supplement 10AP
2003-11-19Labeling · Supplement 7AP
2002-06-04Manufacturing (CMC) · Supplement 4AP
2001-09-17Manufacturing (CMC) · Supplement 3AP
2001-02-21Manufacturing (CMC) · Supplement 1AP
2001-02-21Labeling · Supplement 2AP
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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