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ZORTRESS (nda021560)- (0.25MG,0.5MG,0.75MG,1MG)

EVEROLIMUS NOVARTIS
0.25MG,0.5MG,0.75MG,1MG
Yes No
2020-Mar-09 2014-Mar-30
None 2013-Apr-20
None No
Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:  Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids.  Liver Transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids.
4 0 4
Total Other Developers 11
Drugs with Suitability No
0.25MG ** ** - - 4
0.5MG ** ** - - 4
0.75MG ** ** - - 4
1MG ** ** - - 3
NDA Sales Available Total Generic Sales Available
Yes 4
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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