FDA ANDA · ANDA089097

HYDRALAZINE HYDROCHLORIDE

Sponsor: PLIVA

APPLICATION

ANDA089097

TYPE

ANDA

ORIGINAL APPROVAL

1985-12-18

LATEST ACTION

2014-09-11

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

HYDRALAZINE HYDROCHLORIDEPrescription

HYDRALAZINE HYDROCHLORIDE 10MG · TABLET · ORAL

2014-09-11Manufacturing (CMC) · Supplement 33AP

2013-01-29Labeling · Supplement 34 · standardAP

2010-11-01Labeling · Supplement 23AP

2001-10-11Labeling · Supplement 8AP

2001-06-06Manufacturing (CMC) · Supplement 6AP

2001-05-29Manufacturing (CMC) · Supplement 7AP

2000-07-07Manufacturing (CMC) · Supplement 5AP

1994-05-11Manufacturing (CMC) · Supplement 4AP

1992-02-24Manufacturing (CMC) · Supplement 3AP

1987-04-23Manufacturing (CMC) · Supplement 1AP

1985-12-18OriginalAP

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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