APPLICATION
ANDA080937
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-24
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 68 · standardAP
2024-10-24Labeling · Supplement 63 · standardAP
2024-10-24Labeling · Supplement 62 · standardAP
2000-03-09Manufacturing (CMC) · Supplement 55AP
2000-03-09Manufacturing (CMC) · Supplement 53AP
2000-03-09Manufacturing (CMC) · Supplement 51AP
2000-03-09Manufacturing (CMC) · Supplement 54AP
2000-03-09Labeling · Supplement 52AP
1999-12-21Manufacturing (CMC) · Supplement 56AP
1999-05-20Manufacturing (CMC) · Supplement 50AP
1998-12-01Manufacturing (CMC) · Supplement 49AP
1998-08-10Manufacturing (CMC) · Supplement 48AP
1998-06-15Manufacturing (CMC) · Supplement 47AP
1997-09-18Manufacturing (CMC) · Supplement 45AP
1997-04-07Labeling · Supplement 46AP
1994-12-23Manufacturing (CMC) · Supplement 44AP
1994-10-11Manufacturing (CMC) · Supplement 43AP
1992-04-03Manufacturing (CMC) · Supplement 42AP
1992-04-03Manufacturing (CMC) · Supplement 40AP
1990-01-25Labeling · Supplement 38AP
1989-07-11Labeling · Supplement 37AP
1987-04-06Manufacturing (CMC) · Supplement 35AP
1986-02-21Manufacturing (CMC) · Supplement 29AP
1986-02-21Manufacturing (CMC) · Supplement 33AP
1986-02-21Manufacturing (CMC) · Supplement 28AP
1985-12-13Manufacturing (CMC) · Supplement 31AP
1985-12-13Manufacturing (CMC) · Supplement 26AP
1983-09-07Manufacturing (CMC) · Supplement 22AP
1983-04-26Manufacturing (CMC) · Supplement 21AP
1972-08-24OriginalAP
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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