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REVLIMID(lenalidomide) capsule(二十八)
2013-08-12 23:43:35 来源: 作者: 【 】 浏览:16677次 评论:0
t Code (Source) 59572-405
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LENALIDOMIDE(LENALIDOMIDE) LENALIDOMIDE 5mg
 
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE 147mg
CELLULOSE, MICROCRYSTALLINE 40mg
CROSCARMELLOSE SODIUM 6mg
MAGNESIUM STEARATE 2mg
 
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor  Imprint Code REV;5;mg 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 59572-405-28 28CAPSULEIn1BOTTLE None
2 59572-405-00 100CAPSULEIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021880 12/27/2005 

REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59572-410
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LENALIDOMIDE(LENALIDOMIDE) LENALIDOMIDE 10mg
 
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE 294mg
CELLULOSE, MICROCRYSTALLINE 80mg
CROSCARMELLOSE SODIUM 12mg
MAGNESIUM STEARATE 4mg
 
Product Characteristics
Color GREEN,YELLOW Score no score
Shape CAPSULE Size 22mm
Flavor  Imprint Code REV;10;mg 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 59572-410-28 28CAPSULEIn1BOTTLE None
2 59572-410-00 100CAPSULEIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021880 12/27/2005 

REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59572-415
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LENALIDOMIDE(LENALIDOMIDE) LENALIDOMIDE 15mg
 
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE 289mg
CELLULOSE, MICROCRYSTALLINE 80mg
CROSCARMELLOSE SODIUM 12mg
MAGNESIUM STEARATE 4mg
 
Product Characteristics
Color BLUE,WHITE Score no score
Shape CAPSULE Size 22mm
Flavor  Imprint Code REV;15;mg 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 59572-415-21 21CAPSULEIn1BOTTLE None
2 59572-415-00 100CAPSULEIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021880 06/29/2006 

REVLIMID
lenalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59572-425
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LENALIDOMIDE(LENALIDOMIDE) LENALIDOMIDE 25mg
 
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE 200mg
CELLULOSE, MICROCRYSTALLINE 159mg
CR

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