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)