CAPRELSA
CAPRELSA (vandetanib) Tablets
Approved
Approval ID
a883a3a8-d7a1-8a42-d974-2ba29079b602
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vandetanib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-7860
Product Classification
G
Generic Name
Vandetanib
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (9)
VANDETANIBActive
Quantity: 300 mg in 1 1
Code: YO460OQ37K
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT