APPLICATION
ANDA083633
TYPE
ANDA
ORIGINAL APPROVAL
1976-05-11
LATEST ACTION
2002-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
Approval history
2002-07-24Manufacturing (CMC) · Supplement 21AP
2002-02-08Manufacturing (CMC) · Supplement 20AP
2001-11-02Manufacturing (CMC) · Supplement 18AP
2001-09-24Manufacturing (CMC) · Supplement 19AP
2000-12-18Manufacturing (CMC) · Supplement 16AP
2000-12-18Manufacturing (CMC) · Supplement 14AP
2000-12-18Manufacturing (CMC) · Supplement 17AP
2000-12-18Manufacturing (CMC) · Supplement 15AP
1998-03-17Labeling · Supplement 13AP
1997-03-11Manufacturing (CMC) · Supplement 12AP
1994-03-10Labeling · Supplement 10AP
1992-07-31Manufacturing (CMC) · Supplement 11AP
1988-12-09Labeling · Supplement 9AP
1982-07-19Manufacturing (CMC) · Supplement 8AP
1976-05-11OriginalAP
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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