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COSMEGEN (nda050682)- (0.5MG/VIAL)

DACTINOMYCIN RECORDATI RARE
0.5MG/VIAL
No No
Expired Expired
None None
None No
COSMEGEN is an actinomycin indicated for the treatment of: • adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. • adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. • adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. • adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. • post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. • adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.
4 0 4
Total Other Developers None
Drugs with Suitability No
0.5MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 3
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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