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CARBAGLU (nda022562)- (200MG)

CARGLUMIC ACID RECORDATI RARE
200MG
No No
Expired 2015-Mar-18
2017-Mar-18 None
None No
CARBAGLU is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. • Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).
2 0 2
Total Other Developers 8
Drugs with Suitability No
200MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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