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FDA ANDA · ANDA088570

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA088570
TYPE
ANDA
ORIGINAL APPROVAL
1984-04-10
LATEST ACTION
2020-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 15MG, RESERPINE 0.1MG · TABLET · ORAL

Approval history

2020-08-28Labeling · Supplement 23 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 22AP
1994-12-23Manufacturing (CMC) · Supplement 21AP
1994-10-11Manufacturing (CMC) · Supplement 20AP
1992-04-03Manufacturing (CMC) · Supplement 16AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-03-13Labeling · Supplement 17AP
1991-11-21Labeling · Supplement 15AP
1989-06-16Labeling · Supplement 13AP
1987-12-08Manufacturing (CMC) · Supplement 10AP
1987-10-09Manufacturing (CMC) · Supplement 2AP
1987-04-01Manufacturing (CMC) · Supplement 9AP
1986-09-22Manufacturing (CMC) · Supplement 6AP
1986-09-22Manufacturing (CMC) · Supplement 4AP
1984-04-10OriginalAP
VIEW ON DRUGS@FDA ↗

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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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