APPLICATION
ANDA074069
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-16
LATEST ACTION
2019-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZATHIOPRINEPrescription
AZATHIOPRINE 100MG · TABLET · ORAL
AZATHIOPRINEPrescription
AZATHIOPRINE 50MG · TABLET · ORAL
AZATHIOPRINEPrescription
AZATHIOPRINE 75MG · TABLET · ORAL
Approval history
2019-04-23Labeling · Supplement 14 · standardAP
2017-05-25Manufacturing (CMC) · Supplement 11 · unknownAP
2015-05-19Labeling · Supplement 10 · standardAP
2011-06-21Labeling · Supplement 6AP
2008-10-23Labeling · Supplement 4AP
2007-02-01Labeling · Supplement 3AP
1999-06-22Manufacturing (CMC) · Supplement 1AP
1996-02-16OriginalAP
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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