APPLICATION
ANDA071969
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-14
LATEST ACTION
2001-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, TRIAMTERENE 75MG · TABLET · ORAL
Approval history
2001-04-25Manufacturing (CMC) · Supplement 17AP
1999-09-07Manufacturing (CMC) · Supplement 14AP
1997-08-13Labeling · Supplement 13AP
1993-01-07Labeling · Supplement 12AP
1992-09-28Labeling · Supplement 11AP
1991-10-18Manufacturing (CMC) · Supplement 4AP
1991-10-18Manufacturing (CMC) · Supplement 3AP
1991-08-07Manufacturing (CMC) · Supplement 7AP
1991-03-27Labeling · Supplement 10AP
1991-02-04Labeling · Supplement 9AP
1991-01-28Manufacturing (CMC) · Supplement 8AP
1990-06-29Manufacturing (CMC) · Supplement 6AP
1989-09-18Labeling · Supplement 5AP
1988-03-16Labeling · Supplement 2AP
1988-03-16Manufacturing (CMC) · Supplement 1AP
1988-01-14OriginalAP
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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