Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022156
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEVIPREX CLEVIDIPINE 25MG/50ML (0.5MG/ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
CLEVIPREX CLEVIDIPINE 50MG/100ML (0.5MG/ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
CLEVIPREX CLEVIDIPINE 125MG/250ML (0.5MG/ML) EMULSION;INTRAVENOUS Discontinued None Yes 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
08/01/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022156s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156_cleviprex_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022156s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf

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