Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076582
Company: HIKMA

Products on ANDA 076582

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076582Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076582

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	076582	HIKMA
FENOLDOPAM MESYLATE	FENOLDOPAM MESYLATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077155	SANDOZ