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FDA ANDA · ANDA073357
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA073357
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-27
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 9 · standardAP
2020-08-06Labeling · Supplement 8 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 7AP
1998-12-01Manufacturing (CMC) · Supplement 6AP
1998-06-12Manufacturing (CMC) · Supplement 5AP
1996-08-27Manufacturing (CMC) · Supplement 3AP
1996-08-27Manufacturing (CMC) · Supplement 4AP
1994-01-24Manufacturing (CMC) · Supplement 1AP
1993-11-15Labeling · Supplement 2AP
1991-11-27OriginalAP
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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