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NEBUPENT (nda019887)- (300MG/VIAL,600MG/VIAL)

PENTAMIDINE ISETHIONATE FRESENIUS KABI USA
300MG/VIAL,600MG/VIAL
No No
Expired Expired
None None
None No
NebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.
2 0 2
Total Other Developers None
Drugs with Suitability No
300MG/VIAL ** ** - - -
600MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ***** ****** ******-**** **** ******** ******* ******* *********** **.**, **** ****, ******** *******, ********* *******, **********,, **********, ******, ***** (***) ***

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