zileuton Oral Tablet

Brand(s)
Zyflo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Chiesi Usa, Inc. (2014-06-20)
Oldest Current Product
1996-12-06
License(s)
NDA
RxNORM
ORAL TABLET\ZILEUTON
FDAOB
ORAL\TABLET\ZILEUTON
SPL Active
ORAL\TABLET\ZILEUTON
SPL Moiety
ORAL\TABLET\ZILEUTON

product(s) by strength(s)

zileuton 600 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101220901ZyfloNDAChiesi Usa, Inc.1996-12-06ZILEUTONORALTABLETNDA020471aee65202-fddb-497f-9f11-17cc727cb157

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020471ZYFLOCHIESI USA INC1996-12-09NDA020471_001, NDA020471_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020471_001discontinuedZILEUTON (300MG)ORALTABLETFalse1996-12-09ZYFLO
2NDA020471_003RXZILEUTON (600MG)ORALTABLETTrue1996-12-09ZYFLO

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1aee65202-fddb-497f-9f11-17cc727cb157 (view SPL)ZyfloprescriptionHuman PrescriptionChiesi Usa, Inc.2014-06-2025101220901

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