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AMONDYS 45 (nda213026)- (100MG/2ML (50MG/ML))

CASIMERSEN SAREPTA THERAPS INC
100MG/2ML (50MG/ML)
No No
2030-Nov-12 2026-Feb-25
None None
None No
AMONDYS 45 is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
0 0 0
Total Other Developers None
Drugs with Suitability No
100MG/2ML (50MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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