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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022156
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

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
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