Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213026
Company: SAREPTA THERAPS INC

Products on NDA 213026

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213026

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
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

Labels for NDA 213026

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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