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FDA ANDA · ANDA073334

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS

APPLICATION
ANDA073334
TYPE
ANDA
ORIGINAL APPROVAL
1991-07-19
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
AMILORIDE HYDROCHLORIDE EQ 5MG ANHYDROUS, HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 17 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 16AP
2000-09-13Labeling · Supplement 15AP
2000-03-21Manufacturing (CMC) · Supplement 13AP
1997-07-08Manufacturing (CMC) · Supplement 11AP
1997-05-22Manufacturing (CMC) · Supplement 7AP
1997-05-22Manufacturing (CMC) · Supplement 5AP
1997-05-22Manufacturing (CMC) · Supplement 6AP
1996-12-31Manufacturing (CMC) · Supplement 9AP
1996-12-31Manufacturing (CMC) · Supplement 8AP
1995-06-23Manufacturing (CMC) · Supplement 3AP
1993-09-27Labeling · Supplement 4AP
1991-07-19OriginalAP
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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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