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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211617
Company: ESPERION THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXLIZET BEMPEDOIC ACID; EZETIMIBE 180MG;10MG TABLET;ORAL Prescription None 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
02/26/2020 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211617Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211617Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2023 SUPPL-19 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211616Orig1s015; 211617Orig1s019ltr.pdf
09/20/2023 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211616Orig1s014;211617Orig1s018ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/2023 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf
12/13/2023 SUPPL-19 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf
09/20/2023 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf
02/26/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf
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