APPLICATION
ANDA080936
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-24
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 61 · standardAP
2024-10-24Labeling · Supplement 56 · standardAP
2024-10-24Labeling · Supplement 55 · standardAP
2000-03-16Labeling · Supplement 48AP
2000-03-16Manufacturing (CMC) · Supplement 46AP
2000-03-16Manufacturing (CMC) · Supplement 44AP
2000-03-16Manufacturing (CMC) · Supplement 47AP
2000-03-16Manufacturing (CMC) · Supplement 45AP
1999-12-21Manufacturing (CMC) · Supplement 49AP
1999-05-20Manufacturing (CMC) · Supplement 43AP
1998-12-01Manufacturing (CMC) · Supplement 42AP
1998-06-15Manufacturing (CMC) · Supplement 41AP
1997-09-18Manufacturing (CMC) · Supplement 39AP
1997-04-07Labeling · Supplement 40AP
1994-12-23Manufacturing (CMC) · Supplement 38AP
1994-10-11Manufacturing (CMC) · Supplement 37AP
1992-04-03Manufacturing (CMC) · Supplement 36AP
1992-04-03Manufacturing (CMC) · Supplement 34AP
1990-01-25Labeling · Supplement 32AP
1989-07-11Labeling · Supplement 31AP
1987-04-06Manufacturing (CMC) · Supplement 29AP
1986-02-21Manufacturing (CMC) · Supplement 26AP
1986-02-21Manufacturing (CMC) · Supplement 27AP
1986-02-21Manufacturing (CMC) · Supplement 25AP
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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