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EXONDYS 51 (nda206488)- (100MG/2ML (50MG/ML),500MG/10ML (50MG/ML))

ETEPLIRSEN SAREPTA THERAPS INC
100MG/2ML (50MG/ML),500MG/10ML (50MG/ML)
No No
2034-Mar-14 2021-Sep-19
2023-Sep-19 None
None No
EXONDYS 51 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 51 skipping.
0 0 0
Total Other Developers None
Drugs with Suitability No
100MG/2ML (50MG/ML) ** ** - - -
500MG/10ML (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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