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FDA ANDA · ANDA086881

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA086881
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-10
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL

Approval history

2024-12-19Labeling · Supplement 49 · standardAP
2024-12-19Labeling · Supplement 48 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 44AP
1998-12-01Manufacturing (CMC) · Supplement 42AP
1998-12-01Manufacturing (CMC) · Supplement 41AP
1998-06-10Labeling · Supplement 43AP
1997-10-21Manufacturing (CMC) · Supplement 40AP
1996-02-07Manufacturing (CMC) · Supplement 39AP
1994-06-20Manufacturing (CMC) · Supplement 38AP
1990-12-27Labeling · Supplement 36AP
1990-05-23Labeling · Supplement 37AP
1989-03-31Manufacturing (CMC) · Supplement 34AP
1989-03-31Manufacturing (CMC) · Supplement 35AP
1986-09-29Manufacturing (CMC) · Supplement 30AP
1986-09-29Manufacturing (CMC) · Supplement 33AP
1986-09-29Manufacturing (CMC) · Supplement 31AP
1986-07-17Manufacturing (CMC) · Supplement 29AP
1985-10-08Manufacturing (CMC) · Supplement 24AP
1984-06-29Manufacturing (CMC) · Supplement 27AP
1984-04-11Manufacturing (CMC) · Supplement 26AP
1984-04-11Manufacturing (CMC) · Supplement 25AP
1983-08-11Manufacturing (CMC) · Supplement 22AP
1983-08-11Manufacturing (CMC) · Supplement 23AP
1983-01-27Manufacturing (CMC) · Supplement 18AP
1983-01-27Manufacturing (CMC) · Supplement 19AP
1983-01-27Manufacturing (CMC) · Supplement 21AP
1982-05-24Manufacturing (CMC) · Supplement 16AP
1982-05-24Manufacturing (CMC) · Supplement 17AP
1982-05-19Manufacturing (CMC) · Supplement 6AP
1982-05-19Manufacturing (CMC) · Supplement 4AP
1980-07-10OriginalAP
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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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