core no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code Z;100
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0310-7820-30 30 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022405 06/27/2011
CAPRELSA
vandetanib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-7840
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANDETANIB (VANDETANIB) VANDETANIB 300mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
WATER
POLYETHYLENE GLYCOL 300
Product Characteristics
Color WHITE Score no score
Shape OVAL (biconvex) Size 16mm
Flavor Imprint Code Z;300
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0310-7840-30 30 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022405 06/27/2011
Labeler -AstraZeneca Pharmaceuticals LP (054743190)
Registrant -AstraZeneca PLC (230790719)
Establishment
Name Address ID/FEI Operations
IPR Pharmaceuticals, Inc 156931248 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Lonza AG 480007517 API MANUFACTURE
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