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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019922
Company: HOSPIRA

Products on NDA 019922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORLOPAM	FENOLDOPAM MESYLATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019922_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019922s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019922Orig1s019ltr.pdf
12/17/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019922Orig1s016ltr.pdf
03/22/2006	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/01/2004	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19922se5-005ltr.pdf
07/06/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/13/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019922s019lbl.pdf
12/17/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf
04/01/2004	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf

Therapeutic Equivalents for NDA 019922

CORLOPAM

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

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