entacapone Oral Tablet

Brand(s)
Comtan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sun Pharma Global Fze (2014-11-20)
Oldest Current Product
2000-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ENTACAPONE
FDAOB
ORAL\TABLET\ENTACAPONE
SPL Active
ORAL\TABLET, FILM COATED\ENTACAPONE
SPL Moiety
ORAL\TABLET, FILM COATED\ENTACAPONE

product(s) by strength(s)

entacapone 200 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1646790781NDAWockhardt Usa Llc.2012-09-30ENTACAPONEORALTABLET, FILM COATEDNDA0207963b19e8e3-336c-4aef-8721-ed121e216155

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789080NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2013-06-26ENTACAPONEORALTABLET, FILM COATEDNDA020796e41bbc90-bb83-4514-a38f-994e9fa76472
2473350007NDA AUTHORIZED GENERICSun Pharma Global Fze2013-04-01ENTACAPONEORALTABLET, FILM COATEDNDA020796205522fb-bb0e-414e-a413-a08bef727653
3473350203ANDASun Pharma Global Fze2012-07-18ENTACAPONEORALTABLET, FILM COATEDANDA090690ad6a2b73-29d4-4ced-ba42-4c2ad1c5a1af
4510790273NDA AUTHORIZED GENERICMylan Institutional Inc.2013-12-12ENTACAPONEORALTABLET, FILM COATEDNDA02079682fb6c54-3571-4ea1-9a1b-c21418133e84
5556480290NDA AUTHORIZED GENERICWockhardt Limited2012-09-30ENTACAPONEORALTABLET, FILM COATEDNDA020796f34a7de7-488c-4543-9518-2abe8e651c88
6556480711ANDAWockhardt Limited2012-08-16ENTACAPONEORALTABLET, FILM COATEDANDA078941b9ac99ad-7e82-4064-8c66-214ac6d1776b
7556480781NDA AUTHORIZED GENERICWockhardt Limited2012-09-30ENTACAPONEORALTABLET, FILM COATEDNDA0207965a68fa36-ed25-4309-8624-cd6a0001ec7f
8646790290NDA AUTHORIZED GENERICWockhardt Usa Llc.2012-09-30ENTACAPONEORALTABLET, FILM COATEDNDA020796050eeb2b-a7ba-489a-9e59-a5074ff5f410
9646790711ANDAWockhardt Usa Llc.2012-08-16ENTACAPONEORALTABLET, FILM COATEDANDA07894101ea62f4-bfac-485a-bb4b-a9abb345749f
10658620654ANDAAurobindo Pharma Limited2015-06-19ENTACAPONEORALTABLET, FILM COATEDANDA203437d9cc1327-5474-4136-970a-ec40c41975b2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790166NDA AUTHORIZED GENERICKaiser Foundations Hospitals2014-10-10ENTACAPONEORALTABLET, FILM COATED007815578NDA020796af3ea4f7-7c71-4fd5-8557-9c65ce95606e
2007815578NDA AUTHORIZED GENERICSandoz Inc2014-06-04ENTACAPONEORALTABLET, FILM COATED524830014NDA020796ad4b6d79-efd3-4c43-b4dc-5afdacf939a4
3422910268NDA AUTHORIZED GENERICAvkare, Inc.2014-06-20ENTACAPONEORALTABLET, FILM COATED473350007NDA0207960b0f5d7b-6212-052f-8734-7a524bb60f96
4551543428ComtanNDACardinal Health2000-01-01ENTACAPONEORALTABLET, FILM COATED000780327NDA02079695976f1d-1b36-4f08-a98f-36d5d7883d7b

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA078941ENTACAPONEWOCKHARDT LTD2012-08-16ANDA078941_001
2ANDA090690ENTACAPONESUN PHARMA GLOBAL FZE2012-07-16ANDA090690_001
3ANDA202394ENTACAPONEMYLAN PHARMACEUTICALS INC2013-05-13ANDA202394_001
4ANDA203437ENTACAPONEAUROBINDO PHARMA LTD2015-06-19ANDA203437_001
5NDA020796COMTANORION PHARMA1999-10-19p6599530, TREATMENT OF PARKINSON'S DISEASE, SUBSTANCENDA020796_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078941_001RXENTACAPONE (200MG)ORALTABLETFalseAB2012-08-16ENTACAPONE
2ANDA090690_001RXENTACAPONE (200MG)ORALTABLETFalseAB2012-07-16ENTACAPONE
3ANDA202394_001RXENTACAPONE (200MG)ORALTABLETFalseAB2013-05-13ENTACAPONE
4ANDA203437_001RXENTACAPONE (200MG)ORALTABLETFalseAB2015-06-19ENTACAPONE
5NDA020796_001RXENTACAPONE (200MG)ORALTABLETTrueAB1999-10-19COMTAN

patent(s)

#idexpiration dateapplication(s)
1p6599530 (view patent)2018-09-14NDA020796

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101ea62f4-bfac-485a-bb4b-a9abb345749f (view SPL)Entacapone Tablets, USP*prescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-11-062646790711
2050eeb2b-a7ba-489a-9e59-a5074ff5f410 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionWockhardt Usa Llc.Manufacture2013-07-101646790290
30b0f5d7b-6212-052f-8734-7a524bb60f96 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionAvkare, Inc.2014-06-201422910268
4205522fb-bb0e-414e-a413-a08bef727653 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionSun Pharma Global FzeLABEL, MANUFACTURE, PACK2014-11-204473350007
53b19e8e3-336c-4aef-8721-ed121e216155 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionWockhardt Usa Llc.Analysis, Label, Manufacture, Pack2014-10-222646790781
65a68fa36-ed25-4309-8624-cd6a0001ec7f (view SPL)Entacapone TabletsprescriptionHuman PrescriptionWockhardt LimitedLABEL, MANUFACTURE, PACK2012-09-031556480781
782fb6c54-3571-4ea1-9a1b-c21418133e84 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionMylan Institutional Inc.LABEL, MANUFACTURE, RELABEL, REPACK2013-01-171510790273
895976f1d-1b36-4f08-a98f-36d5d7883d7b (view SPL)COMTAN (entacapone) TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2012-11-094551543428
9ad4b6d79-efd3-4c43-b4dc-5afdacf939a4 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionSandoz Inc2013-12-1710007815578
10ad6a2b73-29d4-4ced-ba42-4c2ad1c5a1af (view SPL)Entacapone Tablets, USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2012-07-182473350203
11af3ea4f7-7c71-4fd5-8557-9c65ce95606e (view SPL)Entacapone TabletsprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-10-241001790166
12b1aceb59-9be8-43b8-83d6-81e05e4b51e4 (view SPL)COMTAN (entacapone) TabletsprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-10-279000780327
13b9ac99ad-7e82-4064-8c66-214ac6d1776b (view SPL)Entacapone Tablets, USP*prescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-11-062556480711
14d9cc1327-5474-4136-970a-ec40c41975b2 (view SPL)Entacapone Tablets, USP Prescribing InformationprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-231658620654
15e41bbc90-bb83-4514-a38f-994e9fa76472 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-10-212003789080
16f34a7de7-488c-4543-9518-2abe8e651c88 (view SPL)Entacapone TabletsprescriptionHuman PrescriptionWockhardt LimitedLabel, Manufacture, Pack2013-07-101556480290

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