APPLICATION
ANDA084217
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-17
LATEST ACTION
2005-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLOROTHIAZIDEDiscontinued
CHLOROTHIAZIDE 500MG · TABLET · ORAL
CHLOROTHIAZIDEDiscontinued
CHLOROTHIAZIDE 250MG · TABLET · ORAL
Approval history
2005-04-04Labeling · Supplement 198AP
2001-02-14Labeling · Supplement 196AP
2001-01-25Manufacturing (CMC) · Supplement 195AP
1998-02-25Manufacturing (CMC) · Supplement 194AP
1998-02-05Manufacturing (CMC) · Supplement 193AP
1996-02-12Labeling · Supplement 192AP
1994-03-11Labeling · Supplement 191AP
1994-02-22Manufacturing (CMC) · Supplement 190AP
1993-03-01Labeling · Supplement 188AP
1990-01-31Manufacturing (CMC) · Supplement 185AP
1989-12-06Labeling · Supplement 187AP
1989-07-13Bioequivalence · Supplement 88AP
1987-11-10Manufacturing (CMC) · Supplement 183AP
1984-09-18Manufacturing (CMC) · Supplement 179AP
1983-02-17Manufacturing (CMC) · Supplement 178AP
1982-03-26Manufacturing (CMC) · Supplement 177AP
1975-07-17OriginalAP
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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