APPLICATION
ANDA088119
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-17
LATEST ACTION
1997-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
Approval history
1997-05-12Labeling · Supplement 15AP
1990-11-09Labeling · Supplement 14AP
1989-11-15Labeling · Supplement 13AP
1989-08-17Labeling · Supplement 11AP
1989-03-21Labeling · Supplement 12AP
1988-03-31Labeling · Supplement 10AP
1985-06-19Manufacturing (CMC) · Supplement 5AP
1985-06-19Manufacturing (CMC) · Supplement 8AP
1985-06-19Manufacturing (CMC) · Supplement 6AP
1985-05-29Manufacturing (CMC) · Supplement 3AP
1985-05-29Manufacturing (CMC) · Supplement 4AP
1983-08-05Manufacturing (CMC) · Supplement 1AP
1983-03-17OriginalAP
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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