tolcapone Oral Tablet

Brand(s)
Tasmar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-10-28)
Oldest Current Product
2004-07-27
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TOLCAPONE
FDAOB
ORAL\TABLET\TOLCAPONE
SPL Active
ORAL\TABLET, COATED\TOLCAPONE
ORAL\TABLET, FILM COATED\TOLCAPONE
SPL Moiety
ORAL\TABLET, COATED\TOLCAPONE
ORAL\TABLET, FILM COATED\TOLCAPONE

product(s) by strength(s)

tolcapone 100 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686820938NDAOceanside Pharmaceuticals2004-07-27TOLCAPONEORALTABLET, FILM COATEDNDA020697dd367eec-359a-4065-b5c3-7c0107c823fe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840254ANDAPar Pharmaceutical Companies, Inc.2015-01-06TOLCAPONEORALTABLET, COATEDANDA204584cad137fb-d18a-4286-94cf-7e79cdeea3f6

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA204584TOLCAPONEPAR PHARMACEUTICAL INC2015-03-26ANDA204584_001
2NDA020697TASMARVALEANT PHARMACEUTICALS NORTH AMERICA LLC1998-01-29NDA020697_001, NDA020697_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA204584_001RXTOLCAPONE (100MG)ORALTABLETFalseAB2015-03-26TOLCAPONE
2NDA020697_001RXTOLCAPONE (100MG)ORALTABLETTrueAB1998-01-29TASMAR
3NDA020697_002discontinuedTOLCAPONE (200MG)ORALTABLETFalse1998-01-29TASMAR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a0e47a9d-78e7-4523-983a-aa259f221736 (view SPL)TASMAR (tolcapone) TABLETSprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-08-018001870938
2cad137fb-d18a-4286-94cf-7e79cdeea3f6 (view SPL)Before prescribing tolcaponethe physician should be thoroughly familiar with the details of this prescribing information.TOLCAPONE TABLETS SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF RISKS SECTION).prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-08-184498840254
3dd367eec-359a-4065-b5c3-7c0107c823fe (view SPL)Tolcapone Tablets 100 mgprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-10-283686820938

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