Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077155
Company: SANDOZ

Products on ANDA 077155

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 077155

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			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077155Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/28/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077155

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