Tetrabenazine Oral Tablet

Brand(s)
Xenazine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-02-01)
Oldest Current Product
2015-07-20
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TETRABENAZINE
FDAOB
ORAL\TABLET\TETRABENAZINE
SPL Active
ORAL\TABLET\TETRABENAZINE
SPL Moiety
ORAL\TABLET\TETRABENAZINE

product(s) by strength(s)

tetrabenazine 12.5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686820421NDAOceanside Pharmaceuticals2015-07-20TETRABENAZINEORALTABLETNDA0218945867189c-17bd-4e70-a079-c4730f9950d1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350277ANDASun Pharma Global Fze2015-08-17TETRABENAZINEORALTABLETANDA206129b7d93006-7f06-4da4-985e-6b948c2468e8

tetrabenazine 25 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686820422NDAOceanside Pharmaceuticals2015-07-20TETRABENAZINEORALTABLETNDA0218945867189c-17bd-4e70-a079-c4730f9950d1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350179ANDASun Pharma Global Fze2015-08-17TETRABENAZINEORALTABLETANDA206129b7d93006-7f06-4da4-985e-6b948c2468e8

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA206129TETRABENAZINESUN PHARMA GLOBAL FZE2015-08-17ANDA206129_001, ANDA206129_002
2NDA021894XENAZINEVALEANT PHARMACEUTICALS NORTH AMERICA LLC2008-08-15ORPHAN DRUG EXCLUSIVITY [2015-08-15]NDA021894_001, NDA021894_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA206129_001RXTETRABENAZINE (12.5MG)ORALTABLETFalseAB2015-08-17TETRABENAZINE
2ANDA206129_002RXTETRABENAZINE (25MG)ORALTABLETFalseAB2015-08-17TETRABENAZINE
3NDA021894_001RXTETRABENAZINE (12.5MG)ORALTABLETFalseAB2008-08-15XENAZINE
4NDA021894_002RXTETRABENAZINE (25MG)ORALTABLETTrueAB2008-08-15XENAZINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15867189c-17bd-4e70-a079-c4730f9950d1 (view SPL)These highlights do not include all the information needed to use Tetrabenazine Tablets safely and effectively. See full prescribing information for Tetrabenazine Tablets. Tetrabenazine Tablets, for Oral use Initial U.S. Approval: 2008prescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-02-012686820421, 686820422
2ac768bab-8afa-4446-bc7f-caeeffec0cda (view SPL)These highlights do not include all the information needed to use XENAZINE safely and effectively. See full prescribing information for XENAZINE Xenazine (tetrabenazine) tablets, for oral use Initial U.S. Approval: 2008prescriptionHuman PrescriptionLundbeck Inc.MANUFACTURE2015-06-039673860421, 673860422
3b7d93006-7f06-4da4-985e-6b948c2468e8 (view SPL)These highlights do not include all the information needed to use TETRABENAZINE safely and effectively. See full prescribing information for TETRABENAZINE TABLETS. TETRABENAZINE tablets, for oral useInitial U.S. Approval: 2008prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-08-184473350179, 473350277

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