FDA ANDA · ANDA088728

HYDRALAZINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION

ANDA088728

TYPE

ANDA

ORIGINAL APPROVAL

1985-04-11

LATEST ACTION

1998-12-01

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued

HYDRALAZINE HYDROCHLORIDE 10MG · TABLET · ORAL

1998-12-01Manufacturing (CMC) · Supplement 14AP

1994-12-23Manufacturing (CMC) · Supplement 13AP

1994-10-11Manufacturing (CMC) · Supplement 12AP

1992-04-03Manufacturing (CMC) · Supplement 9AP

1992-04-03Manufacturing (CMC) · Supplement 11AP

1987-04-08Manufacturing (CMC) · Supplement 6AP

1985-08-09Manufacturing (CMC) · Supplement 1AP

1985-04-11OriginalAP

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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