Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022156
Company: CHIESI
Company: CHIESI
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 |
---|---|---|---|---|---|
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. |
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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 |
---|---|---|---|---|---|
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 |