APPLICATION
ANDA077621
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-15
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZATHIOPRINEPrescription
AZATHIOPRINE 100MG · TABLET · ORAL
AZATHIOPRINEPrescription
AZATHIOPRINE 25MG · TABLET · ORAL
AZATHIOPRINEPrescription
AZATHIOPRINE 75MG · TABLET · ORAL
AZATHIOPRINEPrescription
AZATHIOPRINE 50MG · TABLET · ORAL
Approval history
2025-05-23Labeling · Supplement 21 · standardAP
2019-04-23Labeling · Supplement 13 · standardAP
2015-07-20Labeling · Supplement 8 · standardAP
2011-06-20Labeling · Supplement 5AP
2009-02-17Labeling · Supplement 4AP
2008-09-05Labeling · Supplement 2AP
2007-03-15OriginalAP
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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