dofetilide Oral Capsule

Brand(s)
Tikosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-02-04)
Oldest Current Product
1999-10-01
License(s)
NDA
RxNORM
ORAL CAPSULE\DOFETILIDE
FDAOB
ORAL\CAPSULE\DOFETILIDE
SPL Active
ORAL\CAPSULE\DOFETILIDE
SPL Moiety
ORAL\CAPSULE\DOFETILIDE

product(s) by strength(s)

dofetilide 0.125 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695800TikosynNDAPfizer Labs1999-10-01DOFETILIDEORALCAPSULENDA02093102438044-d6a3-49e9-a1ac-3aad21ef2c8c

dofetilide 0.25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695810TikosynNDAPfizer Labs1999-10-01DOFETILIDEORALCAPSULENDA02093102438044-d6a3-49e9-a1ac-3aad21ef2c8c

dofetilide 0.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695820TikosynNDAPfizer Labs1999-10-01DOFETILIDEORALCAPSULENDA02093102438044-d6a3-49e9-a1ac-3aad21ef2c8c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020931TIKOSYNPFIZER PHARMACEUTICALS PRODUCTION CORP LTD1999-10-01p6124363NDA020931_001, NDA020931_002, NDA020931_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020931_001RXDOFETILIDE (0.125MG)ORALCAPSULEFalse1999-10-01TIKOSYN
2NDA020931_002RXDOFETILIDE (0.25MG)ORALCAPSULEFalse1999-10-01TIKOSYN
3NDA020931_003RXDOFETILIDE (0.5MG)ORALCAPSULETrue1999-10-01TIKOSYN

patent(s)

#idexpiration dateapplication(s)
1p6124363 (view patent)2018-10-09NDA020931

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102438044-d6a3-49e9-a1ac-3aad21ef2c8c (view SPL)TIKOSYN (dofetilide) CapsulesprescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-02-0410000695800, 000695810, 000695820

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