APPLICATION
ANDA086242
TYPE
ANDA
ORIGINAL APPROVAL
1978-10-23
LATEST ACTION
2025-04-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-04-21Labeling · Supplement 51 · standardAP
2025-04-21Labeling · Supplement 44 · standardAP
2010-02-04Labeling · Supplement 29AP
1999-03-04Manufacturing (CMC) · Supplement 17AP
1998-12-07Manufacturing (CMC) · Supplement 16AP
1996-01-31Manufacturing (CMC) · Supplement 15AP
1989-09-12Labeling · Supplement 14AP
1987-10-02Manufacturing (CMC) · Supplement 12AP
1983-06-17Manufacturing (CMC) · Supplement 9AP
1982-09-10Manufacturing (CMC) · Supplement 6AP
1982-06-18Manufacturing (CMC) · Supplement 4AP
1982-06-18Manufacturing (CMC) · Supplement 5AP
1978-10-23OriginalAP
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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