APPLICATION
ANDA087736
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-14
LATEST ACTION
2001-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLOROTHIAZIDEDiscontinued
CHLOROTHIAZIDE 500MG · TABLET · ORAL
Approval history
2001-06-08Manufacturing (CMC) · Supplement 21AP
2000-01-28Manufacturing (CMC) · Supplement 20AP
1998-10-01Manufacturing (CMC) · Supplement 19AP
1996-09-06Labeling · Supplement 18AP
1995-05-24Labeling · Supplement 17AP
1992-07-29Labeling · Supplement 11AP
1991-07-24Manufacturing (CMC) · Supplement 9AP
1991-07-24Manufacturing (CMC) · Supplement 12AP
1991-07-24Manufacturing (CMC) · Supplement 10AP
1991-07-24Manufacturing (CMC) · Supplement 8AP
1990-11-14Bioequivalence · Supplement 13AP
1990-05-04Labeling · Supplement 28AP
1990-05-04Labeling · Supplement 14AP
1985-12-19Manufacturing (CMC) · Supplement 1AP
1985-11-06Manufacturing (CMC) · Supplement 2AP
1982-07-14OriginalAP
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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