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FDA NDA · NDA016324

IMURAN

azathioprine

Sponsor: LEGACY

APPLICATION
NDA016324
TYPE
NDA
ORIGINAL APPROVAL
1968-03-20
LATEST ACTION
2024-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

IMURAN · ReferenceDiscontinued
AZATHIOPRINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
IMURAN · ReferencePrescription
AZATHIOPRINE 50MG · TABLET · ORAL

Approval history

2024-07-09Labeling · Supplement 40 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 39 · standard — Letter ↗AP
2017-11-22Manufacturing (CMC) · Supplement 38 · standard — Letter ↗AP
2014-05-21Manufacturing (CMC) · Supplement 36 · priorityAP
2014-02-06Labeling · Supplement 37 · standard — Letter ↗AP
2011-05-24Labeling · Supplement 34 · unknown — Label ↗AP
2011-05-24Labeling · Supplement 35 · unknown — Letter ↗AP
2008-07-09Labeling · Supplement 31 · standard — Label ↗AP
2005-07-26Labeling · Supplement 30 · standard — Letter ↗AP
2002-12-19Labeling · Supplement 26 · standard — Letter ↗AP
1994-08-30Labeling · Supplement 11AP
1992-10-26Manufacturing (CMC) · Supplement 22 · priorityAP
1992-07-09Manufacturing (CMC) · Supplement 20 · priorityAP
1992-04-28Manufacturing (CMC) · Supplement 21 · priorityAP
1989-10-17Manufacturing (CMC) · Supplement 16 · priorityAP
1988-05-24Manufacturing (CMC) · Supplement 14 · priorityAP
1988-04-18Manufacturing (CMC) · Supplement 17 · priorityAP
1987-02-26Manufacturing (CMC) · Supplement 13 · priorityAP
1981-04-13Efficacy · Supplement 10AP
1980-03-21Manufacturing (CMC) · Supplement 8 · priorityAP
1978-06-07Manufacturing (CMC) · Supplement 7 · priorityAP
1968-03-20Type 1 - New Molecular Entity · Original · priorityAP
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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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