APPLICATION
ANDA087425
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-14
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 38 · standardAP
2025-01-31Labeling · Supplement 36 · standardAP
2025-01-31Labeling · Supplement 34 · standardAP
2008-10-21Labeling · Supplement 31AP
1998-10-01Manufacturing (CMC) · Supplement 26AP
1997-09-08Manufacturing (CMC) · Supplement 23AP
1997-09-08Manufacturing (CMC) · Supplement 22AP
1997-08-12Manufacturing (CMC) · Supplement 19AP
1997-08-12Manufacturing (CMC) · Supplement 25AP
1997-08-12Manufacturing (CMC) · Supplement 24AP
1997-08-12Labeling · Supplement 20AP
1997-02-18Labeling · Supplement 21AP
1995-10-23Manufacturing (CMC) · Supplement 12AP
1995-10-23Manufacturing (CMC) · Supplement 17AP
1995-10-23Labeling · Supplement 15AP
1995-10-23Manufacturing (CMC) · Supplement 13AP
1995-10-23Manufacturing (CMC) · Supplement 18AP
1995-10-23Manufacturing (CMC) · Supplement 16AP
1995-10-23Manufacturing (CMC) · Supplement 14AP
1981-07-14OriginalAP
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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