APPLICATION
ANDA077155
TYPE
ANDA
ORIGINAL APPROVAL
2005-02-15
LATEST ACTION
2023-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FENOLDOPAM MESYLATEDiscontinued
FENOLDOPAM MESYLATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-09-11Labeling · Supplement 4 · standardAP
2023-09-11Labeling · Supplement 5 · standardAP
2008-04-28Labeling · Supplement 1AP
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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