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FDA ANDA · ANDA073209

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: RISING

APPLICATION
ANDA073209
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-08-20Labeling · Supplement 27 · standardAP
2012-01-19Labeling · Supplement 22AP
2003-08-14Labeling · Supplement 8AP
2002-09-18Labeling · Supplement 7AP
2000-08-28Manufacturing (CMC) · Supplement 6AP
2000-05-01Manufacturing (CMC) · Supplement 5AP
1998-02-05Manufacturing (CMC) · Supplement 4AP
1998-01-15Manufacturing (CMC) · Supplement 3AP
1993-05-18Labeling · Supplement 1AP
1991-10-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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