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PREZISTA (nda021976)- (75MG,150MG,300MG,400MG,600MG,800MG)

DARUNAVIR JANSSEN PRODS
75MG,150MG,300MG,400MG,600MG,800MG
Yes No
2027-Jun-26 2011-Jun-23
None None
None No
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.
9 11 9
Total Other Developers 11
Drugs with Suitability No
75MG ** ** - - -
150MG ** ** - - -
300MG ** ** - - -
400MG ** ** - - -
600MG ** ** Up - 9
800MG ** ** Up - 7
NDA Sales Available Total Generic Sales Available
No 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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CIPLA 69097-248 CIPLA LIMITED 917066446 Api manufacture Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND) IND
CIPLA 69097-248 CIPLA LIMITED 916940208 Manufacture Plot No. A-2, A-33, A-42 and A-37/2/2, Patalganga Industrial Area, Raigad, Maharashtra 410220, India (IND) IND
CIPLA 69097-248 INVAGEN PHARMACEUTICALS, INC 080334903 Manufacture 550 S Research Place, Central Islip, New York (NY) 11722, United States (USA) USA
CIPLA 69097-244 CIPLA LIMITED 917066446 Api manufacture Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND) IND
CIPLA 69097-244 CIPLA LIMITED 916940208 Manufacture Plot No. A-2, A-33, A-42 and A-37/2/2, Patalganga Industrial Area, Raigad, Maharashtra 410220, India (IND) IND
CIPLA 69097-244 INVAGEN PHARMACEUTICALS, INC 080334903 Manufacture 550 S Research Place, Central Islip, New York (NY) 11722, United States (USA) USA

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