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HALAVEN(eribulin mesylate)injection(十七)
2016-06-12 13:05:52 来源: 作者: 【 】 浏览:6324次 评论:0
Eisai Inc. Woodcliff Lake, NJ 07677
For more information, go to www.HALAVEN.com or call Eisai Inc. at 1-877-873-4724. If you would like a leaflet with larger printing, please contact Eisai Inc. at 1-877-873-4724.
This Patient Information has been approved by the U.S. Food and Drug Administration.                    Revised: 01/2016
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 62856-389-01
Halaven™
(eribulin mesylate) Injection
1 mg/2 mL
(0.5 mg/mL)
For Intravenous Use
INGREDIENTS AND APPEARANCE
HALAVEN 
eribulin mesylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-389
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERIBULIN MESYLATE (UNII: AV9U0660CW) (ERIBULIN - UNII:LR24G6354G) ERIBULIN MESYLATE 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-389-01 1 in 1 CARTON  
1  2 mL in 1 VIAL; Type 0: Not a Combination Product  
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201532 11/15/2010
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