← FDA DRUG APPROVALS

FDA ANDA · ANDA085022

HYDROCHLOROTHIAZIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA085022
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-01
LATEST ACTION
2002-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCHLOROTHIAZIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 100MG · TABLET · ORAL

Approval history

2002-11-15Manufacturing (CMC) · Supplement 31AP
2002-08-22Manufacturing (CMC) · Supplement 29AP
2002-07-29Manufacturing (CMC) · Supplement 33AP
2002-03-12Manufacturing (CMC) · Supplement 32AP
2000-01-28Manufacturing (CMC) · Supplement 28AP
1999-04-30Manufacturing (CMC) · Supplement 26AP
1999-04-30Manufacturing (CMC) · Supplement 24AP
1999-04-30Manufacturing (CMC) · Supplement 25AP
1998-12-09Manufacturing (CMC) · Supplement 23AP
1998-05-13Manufacturing (CMC) · Supplement 22AP
1998-01-13Manufacturing (CMC) · Supplement 21AP
1997-05-30Manufacturing (CMC) · Supplement 20AP
1997-02-28Manufacturing (CMC) · Supplement 19AP
1995-10-06Manufacturing (CMC) · Supplement 16AP
1995-08-17Labeling · Supplement 18AP
1993-06-07Labeling · Supplement 14AP
1993-06-07Manufacturing (CMC) · Supplement 15AP
1993-03-12Labeling · Supplement 17AP
1993-02-25Manufacturing (CMC) · Supplement 13AP
1989-11-03Manufacturing (CMC) · Supplement 11AP
1989-11-03Manufacturing (CMC) · Supplement 12AP
1989-11-03Manufacturing (CMC) · Supplement 10AP
1988-08-24Bioequivalence · Supplement 1AP
1977-09-01OriginalAP
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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