MedPath
FDA Approval

CAPRELSA

July 1, 2022

HUMAN PRESCRIPTION DRUG LABEL

Vandetanib(300 mg in 1 1)

Manufacturing Establishments (6)

IPR Pharmaceuticals, Inc

Genzyme Corporation

156931248

AstraZeneca Pharmaceuticals LP

Genzyme Corporation

054743190

Lonza AG

Genzyme Corporation

480007517

Penn Pharmaceutical Services Limited

Genzyme Corporation

226277259

EUROAPI UK LIMITED

Genzyme Corporation

229522842

AstraZeneca UK Ltd

Genzyme Corporation

232235408

Products (1)

CAPRELSA

58468-7860

ORAL

August 19, 2022

Code: YO460OQ37KClass: ACTIBQuantity: 300 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
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