FDA ANDA · ANDA070289

TOLAZAMIDE

Sponsor: CHARTWELL RX

APPLICATION

ANDA070289

TYPE

ANDA

ORIGINAL APPROVAL

1986-03-13

LATEST ACTION

2001-05-09

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

TOLAZAMIDEDiscontinued

TOLAZAMIDE 250MG · TABLET · ORAL

2001-05-09Manufacturing (CMC) · Supplement 13AP

1996-04-03Manufacturing (CMC) · Supplement 12AP

1995-10-24Manufacturing (CMC) · Supplement 11AP

1992-07-24Labeling · Supplement 9AP

1990-03-14Manufacturing (CMC) · Supplement 8AP

1989-05-09Labeling · Supplement 7AP

1988-11-08Manufacturing (CMC) · Supplement 6AP

1988-04-04Manufacturing (CMC) · Supplement 1AP

1987-12-22Manufacturing (CMC) · Supplement 4AP

1987-12-22Manufacturing (CMC) · Supplement 2AP

1987-12-22Manufacturing (CMC) · Supplement 3AP

1986-03-13OriginalAP

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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