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RUBRACA (nda209115)- (EQ 200MG BASE,EQ 300MG BASE,EQ 250MG BASE)

RUCAPARIB CAMSYLATE ZR PHARMA
EQ 200MG BASE,EQ 300MG BASE,EQ 250MG BASE
No No
2035-Aug-17 2021-Dec-19
2023-Dec-19 None
None No
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Prostate cancer • for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.
0 0 0
Total Other Developers 1
Drugs with Suitability No
EQ 200MG BASE ** ** - - -
EQ 300MG BASE ** ** - - -
EQ 250MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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