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VISTOGARD (nda208159)- (10GM/PACKET)

URIDINE TRIACETATE BTG INTL
10GM/PACKET
No No
2027-Aug-17 2020-Sep-04
2022-Dec-11 2018-Dec-11
None No
VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients: *following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or *who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
0 0 0
Total Other Developers None
Drugs with Suitability No
10GM/PACKET ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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