APPLICATION
ANDA080136
TYPE
ANDA
ORIGINAL APPROVAL
1970-11-13
LATEST ACTION
2002-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
Approval history
2002-07-24Manufacturing (CMC) · Supplement 36AP
2002-02-08Manufacturing (CMC) · Supplement 35AP
2001-11-02Manufacturing (CMC) · Supplement 33AP
2001-09-24Manufacturing (CMC) · Supplement 34AP
2000-12-18Manufacturing (CMC) · Supplement 31AP
2000-12-18Manufacturing (CMC) · Supplement 32AP
2000-12-18Manufacturing (CMC) · Supplement 30AP
2000-12-18Manufacturing (CMC) · Supplement 29AP
1998-03-17Labeling · Supplement 28AP
1997-03-11Manufacturing (CMC) · Supplement 27AP
1994-03-10Labeling · Supplement 25AP
1992-07-31Manufacturing (CMC) · Supplement 26AP
1988-12-09Labeling · Supplement 24AP
1970-11-13OriginalAP
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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