trandolapril / Verapamil Extended Release Oral Tablet

Brand(s)
Tarka
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2015-05-21)
Oldest Current Product
2005-05-27
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\TRANDOLAPRIL:VERAPAMIL
FDAOB
ORAL\TABLET, EXTENDED RELEASE\TRANDOLAPRIL: VERAPAMIL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TRANDOLAPRIL: VERAPAMIL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TRANDOLAPRIL: TRANDOLAPRILAT: VERAPAMIL
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TRANDOLAPRIL: VERAPAMIL
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TRANDOLAPRILAT: VERAPAMIL

product(s) by strength(s)

24 hr trandolapril 1 mg / verapamil hydrochloride 240 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620152NDAGreenstone Llc2015-02-25TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA020591d776d5d1-cb5b-80f9-e00c-75d4c3ae4d20

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620294ANDAGlenmark Generics Inc., Usa2010-08-30TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07913539bad727-af4c-4d20-933b-7f287e88099a

24 hr trandolapril 2 mg / verapamil hydrochloride 180 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620142NDAGreenstone Llc2015-02-25TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA020591d776d5d1-cb5b-80f9-e00c-75d4c3ae4d20

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620295ANDAGlenmark Generics Inc., Usa2010-05-26TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07913539bad727-af4c-4d20-933b-7f287e88099a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685548TarkaNDAPhysicians Total Care, Inc.2009-01-01TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE000743287NDA0205913b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce9

24 hr trandolapril 2 mg / verapamil hydrochloride 240 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620132NDAGreenstone Llc2015-02-25TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA020591d776d5d1-cb5b-80f9-e00c-75d4c3ae4d20

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620296ANDAGlenmark Generics Inc., Usa2010-05-26TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07913539bad727-af4c-4d20-933b-7f287e88099a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685311TarkaNDAPhysicians Total Care, Inc.2005-05-27TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE000743289NDA0205913b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce9

24 hr trandolapril 4 mg / verapamil hydrochloride 240 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620122NDAGreenstone Llc2015-02-25TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA020591d776d5d1-cb5b-80f9-e00c-75d4c3ae4d20

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620329ANDAGlenmark Generics Inc., Usa2010-05-05TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07913539bad727-af4c-4d20-933b-7f287e88099a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685320TarkaNDAPhysicians Total Care, Inc.2009-06-25TRANDOLAPRIL, VERAPAMIL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE000743290NDA0205913b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA079135TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDEGLENMARK GENERICS LTD2010-05-05ANDA079135_001, ANDA079135_002, ANDA079135_003, ANDA079135_004
2NDA020591TARKAABBVIE INC1996-10-22p5721244NDA020591_001, NDA020591_002, NDA020591_003, NDA020591_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA079135_001RXVERAPAMIL HYDROCHLORIDE (180MG), TRANDOLAPRIL (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-26TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
2ANDA079135_002RXTRANDOLAPRIL (2MG), VERAPAMIL HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-26TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
3ANDA079135_003RXTRANDOLAPRIL (4MG), VERAPAMIL HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-05TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
4ANDA079135_004RXVERAPAMIL HYDROCHLORIDE (240MG), TRANDOLAPRIL (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-08-30TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
5NDA020591_001RXVERAPAMIL HYDROCHLORIDE (180MG), TRANDOLAPRIL (2MG)ORALTABLET, EXTENDED RELEASEFalseAB1996-10-22TARKA
6NDA020591_002RXTRANDOLAPRIL (4MG), VERAPAMIL HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASETrueAB1996-10-22TARKA
7NDA020591_003RXVERAPAMIL HYDROCHLORIDE (240MG), TRANDOLAPRIL (1MG)ORALTABLET, EXTENDED RELEASEFalseAB1996-10-22TARKA
8NDA020591_004RXVERAPAMIL HYDROCHLORIDE (240MG), TRANDOLAPRIL (2MG)ORALTABLET, EXTENDED RELEASEFalseAB1996-10-22TARKA

patent(s)

#idexpiration dateapplication(s)
1p5721244 (view patent)2015-02-24NDA020591

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
139bad727-af4c-4d20-933b-7f287e88099a (view SPL)Trandolapril and Verapamil Hydrochloride Extended-Release TabletsprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-02-206684620294, 684620295, 684620296, 684620329
23b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce9 (view SPL)TARKA(trandolapril/verapamil hydrochloride ER tablets)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-132548685311, 548685320, 548685548
37023927e-1829-49c0-5c81-693489000d1c (view SPL)TARKA(trandolapril/verapamil hydrochloride ER tablets)prescriptionHuman PrescriptionAbbvie Inc.2015-01-151453000743287, 000743288, 000743289, 000743290
4d776d5d1-cb5b-80f9-e00c-75d4c3ae4d20 (view SPL)Trandolapril/verapamil Hydrochloride ER TabletsprescriptionHuman PrescriptionGreenstone Llc2015-05-2120597620122, 597620132, 597620142, 597620152

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