Ticlopidine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2012-09-17)
Oldest Current Product
1999-07-01
License(s)
ANDA
RxNORM
ORAL TABLET\TICLOPIDINE
FDAOB
ORAL\TABLET\TICLOPIDINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\TICLOPIDINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\TICLOPIDINE

product(s) by strength(s)

ticlopidine hydrochloride 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930154ANDATeva Pharmaceuticals Usa Inc1999-09-07TICLOPIDINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075149b1ebcf65-f6c3-4267-99aa-1c6b203dffc7
2576640327ANDACaraco Pharmaceutical Laboratories, Ltd.2002-09-26TICLOPIDINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075526aa3b8a6e-c60c-47e3-8ccf-54d73c7e42aa
3605050027ANDAApotex Corp1999-07-01TICLOPIDINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075089707127cb-cdcd-81b0-274d-3c11fefa6824

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850115ANDAEon Labs, Inc.1999-08-20TICLOPIDINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0753260f96e04b-436f-477f-98b3-8668c7ee84ee

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681510079ANDACarilion Materials Management1999-09-07TICLOPIDINE HYDROCHLORIDEORALTABLET, FILM COATED000930154ANDA07514977d619f8-05a3-408a-a6f8-1511694b6a24

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075089TICLOPIDINE HYDROCHLORIDEAPOTEX INC1999-07-01ANDA075089_001
2ANDA075149TICLOPIDINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC1999-08-20ANDA075149_001
3ANDA075161TICLOPIDINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC1999-09-13ANDA075161_001
4ANDA075253TICLOPIDINE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC1999-08-20ANDA075253_001
5ANDA075309TICLOPIDINE HYDROCHLORIDETrueWATSON LABORATORIES INC2000-04-26ANDA075309_001
6ANDA075316TICLOPIDINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC1999-11-02ANDA075316_001
7ANDA075318TICLOPIDINE HYDROCHLORIDETrueSANDOZ INC1999-08-20ANDA075318_001
8ANDA075326TICLOPIDINE HYDROCHLORIDETrueSANDOZ INC1999-08-20ANDA075326_001
9ANDA075526TICLOPIDINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2002-09-26ANDA075526_001
10NDA019979TICLIDTrueROCHE PALO ALTO LLC1991-10-31NDA019979_001, NDA019979_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075089_001RXTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalseAB1999-07-01TICLOPIDINE HYDROCHLORIDE
2ANDA075149_001RXTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETTrueAB1999-08-20TICLOPIDINE HYDROCHLORIDE
3ANDA075161_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1999-09-13TICLOPIDINE HYDROCHLORIDE
4ANDA075253_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1999-08-20TICLOPIDINE HYDROCHLORIDE
5ANDA075309_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse2000-04-26TICLOPIDINE HYDROCHLORIDE
6ANDA075316_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1999-11-02TICLOPIDINE HYDROCHLORIDE
7ANDA075318_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1999-08-20TICLOPIDINE HYDROCHLORIDE
8ANDA075326_001discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1999-08-20TICLOPIDINE HYDROCHLORIDE
9ANDA075526_001RXTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalseAB2002-09-26TICLOPIDINE HYDROCHLORIDE
10NDA019979_001discontinuedTICLOPIDINE HYDROCHLORIDE (125MG)ORALTABLETFalse1993-03-24TICLID
11NDA019979_002discontinuedTICLOPIDINE HYDROCHLORIDE (250MG)ORALTABLETFalse1991-10-31TICLID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f96e04b-436f-477f-98b3-8668c7ee84ee (view SPL)Ticlopidine Hydrochloride Tablets, 250 mgprescriptionHuman PrescriptionEon Labs, Inc.2011-06-223001850115
2707127cb-cdcd-81b0-274d-3c11fefa6824 (view SPL)TICLOPIDINE HYDROCHLORIDE TABLETS, USP 250 mg Rx OnlyprescriptionHuman PrescriptionApotex Corp2011-11-033605050027
377d619f8-05a3-408a-a6f8-1511694b6a24 (view SPL)TICLOPIDINE HYDROCHLORIDE TABLETS USP 0154 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-09-172681510079
4aa3b8a6e-c60c-47e3-8ccf-54d73c7e42aa (view SPL)TICLOPIDINE HYDROCHLORIDE TABLETS, USP 250mgRx onlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2013-05-231576640327
5b1ebcf65-f6c3-4267-99aa-1c6b203dffc7 (view SPL)TICLOPIDINE HYDROCHLORIDE TABLETS USP 0154Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-09-173000930154

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