APPLICATION
ANDA086795
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-15
LATEST ACTION
1997-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLOROTHIAZIDEDiscontinued
CHLOROTHIAZIDE 250MG · TABLET · ORAL
Approval history
1997-05-23Manufacturing (CMC) · Supplement 16AP
1996-05-01Labeling · Supplement 15AP
1996-03-05Manufacturing (CMC) · Supplement 14AP
1996-02-05Labeling · Supplement 13AP
1992-11-25Labeling · Supplement 12AP
1989-10-30Labeling · Supplement 11AP
1989-06-08Labeling · Supplement 10AP
1989-03-29Labeling · Supplement 9AP
1988-09-20Manufacturing (CMC) · Supplement 8AP
1988-09-20Manufacturing (CMC) · Supplement 6AP
1988-09-20Manufacturing (CMC) · Supplement 7AP
1988-06-08Labeling · Supplement 5AP
1986-08-05Manufacturing (CMC) · Supplement 3AP
1985-10-24Manufacturing (CMC) · Supplement 2AP
1984-08-06Manufacturing (CMC) · Supplement 1AP
1983-08-15OriginalAP
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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