APPLICATION
NDA008428
TYPE
NDA
LATEST ACTION
1980-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
ISONIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
ISONIAZIDDiscontinued
ISONIAZID 50MG · TABLET · ORAL
Approval history
1980-04-03Manufacturing (CMC) · Supplement 23 · standardAP
1979-06-14Manufacturing (CMC) · Supplement 22 · standardAP
1978-11-07Manufacturing (CMC) · Supplement 20 · standardAP
1978-06-19Labeling · Supplement 14AP
1978-06-19Labeling · Supplement 15AP
1978-06-13Labeling · Supplement 13AP
1978-04-20Manufacturing (CMC) · Supplement 12 · standardAP
1977-07-25Labeling · Supplement 10AP
1977-04-13Labeling · Supplement 8AP
1977-04-06Labeling · Supplement 9AP
1976-03-01Labeling · Supplement 7AP
1973-06-11Supplement · Supplement 3 · 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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