fidaxomicin Oral Tablet

Brand(s)
Dificid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cubist Pharmaceuticals U.S. (2014-05-29)
Oldest Current Product
2011-05-27
License(s)
NDA
RxNORM
ORAL TABLET\FIDAXOMICIN
FDAOB
ORAL\TABLET\FIDAXOMICIN
SPL Active
ORAL\TABLET, FILM COATED\FIDAXOMICIN
SPL Moiety
ORAL\TABLET, FILM COATED\FIDAXOMICIN

product(s) by strength(s)

fidaxomicin 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1520150080DificidNDACubist Pharmaceuticals U.S.2011-05-27FIDAXOMICINORALTABLET, FILM COATEDNDA201699dd966338-c820-4270-b704-09ef75fa3ceb

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201699DIFICIDCUBIST PHARMACEUTICALS LLC2011-05-27p7378508, SUBSTANCE
p8859510, TREATMENT OF MICROBIAL INFECTIONS
p7906489, TREATMENT OF MICROBIAL INFECTIONS
p8586551, SUBSTANCE
p7863249, SUBSTANCE
NEW CHEMICAL ENTITY [2016-05-27]NDA201699_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201699_001RXFIDAXOMICIN (200MG)ORALTABLETTrue2011-05-27DIFICID

patent(s)

#idexpiration dateapplication(s)
1p7378508 (view patent)2027-07-31NDA201699
2p7863249 (view patent)2027-07-31NDA201699
3p7906489 (view patent)2027-03-04NDA201699
4p8586551 (view patent)2024-04-12NDA201699
5p8859510 (view patent)2027-07-31NDA201699

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1dd966338-c820-4270-b704-09ef75fa3ceb (view SPL)These highlights do not include all the information needed to use DIFICID safely and effectively. See full prescribing information for DIFICID. DIFICID (fidaxomicin) tablets, for oral useInitial U.S. approval: 2011 To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.prescriptionHuman PrescriptionCubist Pharmaceuticals U.S.analysis, api manufacture, manufacture2014-05-294520150080

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