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New Drug Application (NDA): 213026
Company: SAREPTA THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMONDYS 45 CASIMERSEN 100MG/2ML (50MG/ML) SOLUTION;INTRAVENOUS 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
02/25/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213026Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213026Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2024 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213026s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213026Orig1s008ltr.pdf
03/23/2023 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213026s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213026Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/11/2024 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213026s008lbl.pdf
03/23/2023 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213026s005lbl.pdf
02/25/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213026lbl.pdf
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