APPLICATION
ANDA080212
TYPE
ANDA
ORIGINAL APPROVAL
1972-02-28
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
ISONIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 43 · standardAP
2025-01-31Labeling · Supplement 39 · standardAP
2025-01-31Labeling · Supplement 41 · standardAP
2008-10-31Labeling · Supplement 37AP
1998-10-01Manufacturing (CMC) · Supplement 32AP
1997-08-13Manufacturing (CMC) · Supplement 30AP
1997-08-13Manufacturing (CMC) · Supplement 31AP
1997-02-18Labeling · Supplement 29AP
1995-10-23Manufacturing (CMC) · Supplement 18AP
1995-10-23Manufacturing (CMC) · Supplement 24AP
1995-10-23Manufacturing (CMC) · Supplement 22AP
1995-10-23Manufacturing (CMC) · Supplement 20AP
1995-10-23Manufacturing (CMC) · Supplement 19AP
1995-10-23Manufacturing (CMC) · Supplement 23AP
1995-10-23Labeling · Supplement 21AP
1995-06-23Manufacturing (CMC) · Supplement 28AP
1995-06-23Labeling · Supplement 26AP
1995-06-23Manufacturing (CMC) · Supplement 27AP
1995-06-23Manufacturing (CMC) · Supplement 25AP
1991-04-15Manufacturing (CMC) · Supplement 15AP
1982-01-28Manufacturing (CMC) · Supplement 6AP
1972-02-28OriginalAP
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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