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FDA NDA · NDA213026

AMONDYS 45

casimersen

Sponsor: SAREPTA THERAPS INC

APPLICATION
NDA213026
TYPE
NDA
ORIGINAL APPROVAL
2021-02-25
LATEST ACTION
2026-01-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AMONDYS 45 · ReferencePrescription
CASIMERSEN 100MG/2ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-01-06Labeling · Supplement 16 · standardLetterAP
2024-07-11Labeling · Supplement 8 · standardLetterAP
2023-03-23Labeling · Supplement 5 · standardLetterAP
2021-02-25Type 1 - New Molecular Entity · Original · priorityLabelAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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