APPLICATION
ANDA070259
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-07
LATEST ACTION
2010-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLAZAMIDEDiscontinued
TOLAZAMIDE 500MG · TABLET · ORAL
TOLAZAMIDEDiscontinued
TOLAZAMIDE 250MG · TABLET · ORAL
Approval history
2010-03-10Labeling · Supplement 23AP
2009-11-20Labeling · Supplement 22AP
2002-01-10Labeling · Supplement 16AP
2000-03-10Labeling · Supplement 15AP
1999-09-20Manufacturing (CMC) · Supplement 14AP
1998-02-25Manufacturing (CMC) · Supplement 12AP
1998-02-05Manufacturing (CMC) · Supplement 13AP
1993-11-15Manufacturing (CMC) · Supplement 10AP
1991-03-26Labeling · Supplement 8AP
1991-02-05Labeling · Supplement 7AP
1990-01-31Manufacturing (CMC) · Supplement 6AP
1989-07-27Labeling · Supplement 5AP
1986-11-07OriginalAP
1986-03-21Manufacturing (CMC) · Supplement 1AP
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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