Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077155
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOLDOPAM MESYLATE FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/15/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2008 SUPPL-1 Labeling

Label is not available on this site.

FENOLDOPAM MESYLATE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORLOPAM FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019922 HOSPIRA
FENOLDOPAM MESYLATE FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077155 SANDOZ INC
FENOLDOPAM MESYLATE FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076582 WEST-WARD PHARMS INT

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