An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022156
Company: CHIESI

Summary Review

Products on NDA 022156

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022156

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
04/16/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022156s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022156Orig1s007ltr.pdf
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

Labels for NDA 022156

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022156s007lbl.pdf
12/08/2011	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf

Top