Ethotoin Oral Tablet

Brand(s)
Peganone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Recordati Rare Diseases, Inc. (2013-02-01)
Oldest Current Product
1957-04-22
License(s)
NDA
RxNORM
ORAL TABLET\ETHOTOIN
FDAOB
ORAL\TABLET\ETHOTOIN
SPL Active
ORAL\TABLET\ETHOTOIN
SPL Moiety
ORAL\TABLET\ETHOTOIN

product(s) by strength(s)

ethotoin 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1552920601PeganoneNDARecordati Rare Diseases, Inc.1957-04-22ETHOTOINORALTABLETNDA010841afcb9d60-3668-3890-5fed-f0794a12509d

application(s)

#idtitleapplicantapproved drug
1NDA010841PEGANONERECORDATI RARE DISEASES INCNDA010841_001, NDA010841_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1NDA010841_001RXETHOTOIN (250MG)ORALTABLETTruePEGANONE
2NDA010841_003discontinuedETHOTOIN (500MG)ORALTABLETFalsePEGANONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1afcb9d60-3668-3890-5fed-f0794a12509d (view SPL)PEGANONE 250 mg Tablets(ethotoin tablets, USP) RxonlyprescriptionHuman PrescriptionRecordati Rare Diseases, Inc.MANUFACTURE2013-02-011552920601

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