me Basis of Strength Strength
VANDETANIB (VANDETANIB) VANDETANIB 300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONES
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
1 NDC:0310-7840-30 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022405 07/25/2011
Labeler - AstraZeneca Pharmaceuticals LP (054743190)
Registrant - AstraZeneca PLC (230790719)
Establishment
Name Address ID/FEI Operations
IPR Pharmaceuticals, Inc 156931248 MANUFACTURE(0310-7820, 0310-7840)
Revised: 07/2013
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