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FDA ANDA · ANDA088467

HYDRALAZINE HYDROCHLORIDE

Sponsor: PLIVA

APPLICATION
ANDA088467
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-01
LATEST ACTION
2013-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDRALAZINE HYDROCHLORIDE · ReferencePrescription
HYDRALAZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2013-04-26Labeling · Supplement 42 · standardAP
2013-01-28Labeling · Supplement 40 · standardAP
2010-11-01Labeling · Supplement 29AP
2001-10-11Labeling · Supplement 14AP
2001-06-08Manufacturing (CMC) · Supplement 13AP
2000-07-07Manufacturing (CMC) · Supplement 12AP
1994-05-11Manufacturing (CMC) · Supplement 11AP
1990-04-04Manufacturing (CMC) · Supplement 10AP
1988-03-25Labeling · Supplement 8AP
1986-07-22Manufacturing (CMC) · Supplement 6AP
1986-06-04Manufacturing (CMC) · Supplement 7AP
1986-02-21Manufacturing (CMC) · Supplement 5AP
1985-05-22Manufacturing (CMC) · Supplement 4AP
1985-03-15Manufacturing (CMC) · Supplement 3AP
1985-03-15Manufacturing (CMC) · Supplement 2AP
1984-05-01OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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