APPLICATION
ANDA074419
TYPE
ANDA
ORIGINAL APPROVAL
1995-03-31
LATEST ACTION
2024-07-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZATHIOPRINE SODIUMPrescription
AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-07-09Labeling · Supplement 18 · standardAP
2021-01-07Labeling · Supplement 15 · standardAP
2014-03-24Labeling · Supplement 11 · standardAP
2012-08-09Labeling · Supplement 8AP
2011-07-27Labeling · Supplement 6AP
2000-11-30Manufacturing (CMC) · Supplement 2AP
1998-08-18Manufacturing (CMC) · Supplement 1AP
1995-03-31OriginalAP
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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