U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212728
Company: BIOHAVEN IRELAND
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NURTEC ODT RIMEGEPANT SULFATE EQ 75MG BASE TABLET, ORALLY DISINTEGRATING;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
02/27/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212728Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2022 SUPPL-14 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212728Orig1s014ltr.pdf
12/08/2021 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212728Orig1s012ltr.pdf
04/11/2022 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212728s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212728Orig1s009ltr.pdf
05/27/2021 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212728Orig1s006ltr.pdf
08/18/2020 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212728Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2022 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212728s009lbl.pdf
12/08/2021 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s012lbl.pdf
05/27/2021 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf
08/18/2020 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s001lbl.pdf
02/27/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf
Back to Top