VELETRI epoprostenol injection powder lyophilized for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

EPOPROSTENOL (UNII: DCR9Z582X0) (EPOPROSTENOL - UNII:DCR9Z582X0)

متاح من:

Jubilant HollisterStier General Partnership

INN (الاسم الدولي):

EPOPROSTENOL

تركيب:

EPOPROSTENOL 1500000 ng in 10 mL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

خصائص المنتج

VELETRI- EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP
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VELETRI
PRINCIPAL DISPLAY PANEL 1
VELETRI 1.5MG CARTON
VELETRI
epoprostenol injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:76 112-40 2
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Jubilant HollisterStier General Partnership
EPO PRO STENO L (UNII: DCR9 Z58 2X0 ) (EPOPROSTENOL - UNII:DCR9 Z58
2X0 )
EPOPROSTENOL
150 0 0 0 0 ng in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ARGININE (UNII: 9 4ZLA3W45F)
SUCRO SE (UNII: C151H8 M554)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 112-40 2-0 1
1 in 1 CARTON
0 4/22/20 10
1
10 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR
MONOGRAPH CITATION
MARKE TING START
DATE
MARKE TING END
DATE
APPROVED DRUG PRODUCT MANUFACTURED
UNDER CONTRACT
NDA0 2226 0
0 4/22/20 10
LABELER -
Jubilant HollisterStier General Partnership (246762764)
Revised: 11/2017