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DEFITELIO (nda208114)- (200MG/2.5ML (80MG/ML))

DEFIBROTIDE SODIUM JAZZ PHARMS INC
200MG/2.5ML (80MG/ML)
No No
2032-Jun-22 2021-Mar-30
2023-Mar-30 None
None No
DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
0 0 0
Total Other Developers None
Drugs with Suitability No
200MG/2.5ML (80MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 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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