APPLICATION
ANDA089098
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 100MG · TABLET · ORAL
Approval history
2014-09-11Manufacturing (CMC) · Supplement 32AP
2013-01-29Labeling · Supplement 33 · standardAP
2010-11-01Labeling · Supplement 23AP
2001-10-11Labeling · Supplement 8AP
2001-06-15Manufacturing (CMC) · Supplement 6AP
2001-05-29Manufacturing (CMC) · Supplement 7AP
2000-07-07Manufacturing (CMC) · Supplement 5AP
1994-05-11Manufacturing (CMC) · Supplement 4AP
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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