APPLICATION
ANDA040730
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-21
LATEST ACTION
2021-03-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HYDRALAZINE HYDROCHLORIDEPrescription
HYDRALAZINE HYDROCHLORIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
2021-03-09Labeling · Supplement 4 · standardAP
2015-05-07Labeling · Supplement 2AP
2009-04-21OriginalAP
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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