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SYMDEKO (COPACKAGED) (nda210491)- (75MG;75MG, 50MG,150MG;150MG, 100MG)

IVACAFTOR; IVACAFTOR, TEZACAFTOR VERTEX PHARMS INC
75MG;75MG, 50MG,150MG;150MG, 100MG
No No
2035-Apr-14 2023-Feb-12
None None
None No
SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
0 0 0
Total Other Developers None
Drugs with Suitability No
75MG;75MG, 50MG ** ** - - -
150MG;150MG, 100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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