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NAMENDA XR ® (memantine hydrochloride) extended release capsules (十九)
2016-08-22 10:38:18 来源: 作者: 【 】 浏览:6838次 评论:0
d Date
NDA NDA022525 09/15/2011 
 
Part 4 of 4
NAMENDA  XR
 memantine hydrochloride capsule, extended release
 
Product Information

Route of Administration ORAL
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
memantine hydrochloride (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T) memantine hydrochloride 28 mg
 
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)  
povidone K30 (UNII: U725QWY32X)  
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
talc (UNII: 7SEV7J4R1U)  
polyethylene glycol 400 (UNII: B697894SGQ)  
polyethylene glycol 8000 (UNII: Q662QK8M3B)  
ethylcellulose (100 MPA.S) (UNII: 47MLB0F1MV)  
ammonia (UNII: 5138Q19F1X)  
 
Product Characteristics
Color GREEN (DARK GREEN (OPAQUE)) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor  Imprint Code FLI;28;mg
Contains     

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022525 09/15/2011 
Labeler - Forest Laboratories, Inc. (001288281) 
Establishment
Name Address ID/FEI Business Operations
Forest Laboratories, Ireland Ltd.  896303588 MANUFACTURE(0456-3407, 0456-3414, 0456-3421, 0456-3428, 0456-3400)  

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