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OLPRUVA (NDA214860)- (2GM/PACKET,3GM/PACKET,4GM/PACKET,5GM/PACKET,6GM/PACKET,6.67GM/PACKET)

SODIUM PHENYLBUTYRATE ACER
2GM/PACKET,3GM/PACKET,4GM/PACKET,5GM/PACKET,6GM/PACKET,6.67GM/PACKET
No Yes
2036-Oct-17 Expired
None None
None No
OLPRUVA is a nitrogen-binding agent indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
0 0 0
Total Other Developers None
Drugs with Suitability No
2GM/PACKET ** ** - - -
3GM/PACKET ** ** - - -
4GM/PACKET ** ** - - -
5GM/PACKET ** ** - - -
6GM/PACKET ** ** - - -
6.67GM/PACKET ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
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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