APPLICATION
NDA008678
TYPE
NDA
ORIGINAL APPROVAL
1952-11-17
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZID · ReferenceDiscontinued
ISONIAZID 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ISONIAZID · ReferenceDiscontinued
ISONIAZID 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-07-13Manufacturing (CMC) · Supplement 23 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 22 · standardAP
1997-03-06Labeling · Supplement 21 · standardAP
1996-08-01Labeling · Supplement 19 · standardAP
1995-11-21Manufacturing (CMC) · Supplement 20 · standardAP
1992-08-10Manufacturing (CMC) · Supplement 18 · standardAP
1992-08-10Manufacturing (CMC) · Supplement 17 · standardAP
1988-09-23Manufacturing (CMC) · Supplement 16 · standardAP
1987-09-10Labeling · Supplement 14AP
1985-05-09Manufacturing (CMC) · Supplement 15 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 12 · standardAP
1983-08-19Manufacturing (CMC) · Supplement 11 · standardAP
1983-08-19Manufacturing (CMC) · Supplement 10 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 9 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 8 · standardAP
1980-09-30Manufacturing (CMC) · Supplement 7 · standardAP
1952-11-17Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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