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BALVERSA (nda212018)- (3MG,4MG,5MG)

ERDAFITINIB JANSSEN BIOTECH
3MG,4MG,5MG
Yes No
2038-Feb-02 2024-Apr-12
None None
None No
BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
0 0 0
Total Other Developers 1
Drugs with Suitability No
3MG ** ** - - -
4MG ** ** - - -
5MG ** ** - - -
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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