Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019922
Company: HOSPIRA
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
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
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-Package Insert, Labeling-Container/Carton Labels

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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 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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