Vandetanib Oral Tablet

Brand(s)
Caprelsa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2011-04-13)
Oldest Current Product
2011-04-21
License(s)
NDA
RxNORM
ORAL TABLET\VANDETANIB
FDAOB
ORAL\TABLET\VANDETANIB
SPL Active
ORAL\TABLET\VANDETANIB
SPL Moiety
ORAL\TABLET\VANDETANIB

product(s) by strength(s)

vandetanib 100 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003107810NDAAstrazeneca Pharmaceuticals Lp2011-04-21VANDETANIBORALTABLETNDA022405d2a87691-c9ad-4753-97a1-311fccfe6515

vandetanib 300 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003107830NDAAstrazeneca Pharmaceuticals Lp2011-04-21VANDETANIBORALTABLETNDA022405d2a87691-c9ad-4753-97a1-311fccfe6515

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022405CAPRELSAIPR PHARMACEUTICALS INC2011-04-06p8642608, FOR USE IN PATIENTS HAVING SYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER
p7173038, SUBSTANCE
pRE42353, SUBSTANCE
p8067427, SUBSTANCE
NEW CHEMICAL ENTITY [2016-04-06]
ORPHAN DRUG EXCLUSIVITY [2018-04-06]
NDA022405_001, NDA022405_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022405_001RXVANDETANIB (100MG)ORALTABLETFalse2011-04-06CAPRELSA
2NDA022405_002RXVANDETANIB (300MG)ORALTABLETTrue2011-04-06CAPRELSA

patent(s)

#idexpiration dateapplication(s)
1p7173038 (view patent)2021-08-14NDA022405
2p8067427 (view patent)2028-08-08NDA022405
3p8642608 (view patent)2022-02-06NDA022405
4pRE42353 (view patent)2017-09-23NDA022405

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14dc7f0af-77fb-4eec-46b9-dd1c2dcb4525 (view SPL)These highlights do not include all the information needed to use CAPRELSA safely and effectively. See full prescribing information for CAPRELSA.CAPRELSA (vandetanib) Tablets for Oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals LpMANUFACTURE2014-03-3112003107820, 003107840
2d2a87691-c9ad-4753-97a1-311fccfe6515 (view SPL)These highlights do not include all the information needed to use vandetanib safely and effectively. See full prescribing information for vandetanib.Initial U.S. Approval: 2011prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals LpAPI MANUFACTURE, MANUFACTURE2011-04-133003107810, 003107830

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII