Dolasetron Oral Tablet

Brand(s)
Anzemet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-10-01)
Oldest Current Product
1997-09-11
License(s)
NDA
RxNORM
ORAL TABLET\DOLASETRON
FDAOB
ORAL\TABLET\DOLASETRON MESYLATE
SPL Active
ORAL\TABLET, FILM COATED\DOLASETRON MESYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\DOLASETRON

product(s) by strength(s)

dolasetron 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000881203AnzemetNDASanofi-Aventis U.S. Llc1997-09-11DOLASETRON MESYLATEORALTABLET, FILM COATEDNDA0206233df5f9f0-d374-425f-8a6d-e58fbfb8ea04

dolasetron 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000881202AnzemetNDASanofi-Aventis U.S. Llc1997-09-11DOLASETRON MESYLATEORALTABLET, FILM COATEDNDA0206233df5f9f0-d374-425f-8a6d-e58fbfb8ea04

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020623ANZEMETSANOFI AVENTIS US LLC1997-09-11NDA020623_001, NDA020623_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020623_001RXDOLASETRON MESYLATE (50MG)ORALTABLETFalse1997-09-11ANZEMET
2NDA020623_002RXDOLASETRON MESYLATE (100MG)ORALTABLETTrue1997-09-11ANZEMET

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13df5f9f0-d374-425f-8a6d-e58fbfb8ea04 (view SPL)ANZEMET Tablets (dolasetron mesylate)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2014-10-0114000881202, 000881203

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