APPLICATION
ANDA075252
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-07
LATEST ACTION
2025-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AZASANPrescription
AZATHIOPRINE 25MG · TABLET · ORAL
AZASANPrescription
AZATHIOPRINE 75MG · TABLET · ORAL
AZASANPrescription
AZATHIOPRINE 50MG · TABLET · ORAL
AZASANPrescription
AZATHIOPRINE 100MG · TABLET · ORAL
Approval history
2025-05-07Labeling · Supplement 27 · standardAP
2025-05-07Labeling · Supplement 26 · standardAP
2023-11-28Labeling · Supplement 23 · standardAP
2022-01-11Labeling · Supplement 21 · standardAP
2015-09-02Labeling · Supplement 17AP
2015-09-02Labeling · Supplement 18 · standardAP
2006-09-13Labeling · Supplement 15AP
2006-03-02Labeling · Supplement 14AP
2003-02-03Labeling · Supplement 11AP
2003-02-03Labeling · Supplement 8AP
2003-02-03Manufacturing (CMC) · Supplement 6AP
2003-02-03Manufacturing (CMC) · Supplement 10AP
2003-02-03Manufacturing (CMC) · Supplement 9AP
2003-02-03Manufacturing (CMC) · Supplement 7AP
2003-02-03Manufacturing (CMC) · Supplement 5AP
2002-08-14Manufacturing (CMC) · Supplement 4AP
2001-07-18Manufacturing (CMC) · Supplement 2AP
2001-07-18Labeling · Supplement 3AP
2000-11-20Manufacturing (CMC) · Supplement 1AP
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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