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FDA ANDA · ANDA086028

CHLOROTHIAZIDE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA086028
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-14
LATEST ACTION
2001-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLOROTHIAZIDEDiscontinued
CHLOROTHIAZIDE 250MG · TABLET · ORAL

Approval history

2001-06-14Manufacturing (CMC) · Supplement 23AP
2000-01-28Manufacturing (CMC) · Supplement 22AP
1998-10-01Manufacturing (CMC) · Supplement 21AP
1996-09-06Labeling · Supplement 20AP
1995-05-24Labeling · Supplement 19AP
1992-07-29Labeling · Supplement 16AP
1991-04-16Manufacturing (CMC) · Supplement 14AP
1991-04-16Manufacturing (CMC) · Supplement 15AP
1990-05-04Labeling · Supplement 18AP
1988-07-06Manufacturing (CMC) · Supplement 5AP
1988-07-06Manufacturing (CMC) · Supplement 12AP
1988-07-06Manufacturing (CMC) · Supplement 10AP
1988-07-06Manufacturing (CMC) · Supplement 8AP
1988-07-06Manufacturing (CMC) · Supplement 6AP
1988-07-06Manufacturing (CMC) · Supplement 11AP
1988-07-06Manufacturing (CMC) · Supplement 9AP
1988-07-06Manufacturing (CMC) · Supplement 7AP
1985-10-24Manufacturing (CMC) · Supplement 1AP
1982-07-14OriginalAP
VIEW ON DRUGS@FDA ↗

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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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