trandolapril Oral Tablet

Brand(s)
Mavik
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2015-01-07)
Oldest Current Product
1996-04-26
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TRANDOLAPRIL
FDAOB
ORAL\TABLET\TRANDOLAPRIL
SPL Active
ORAL\TABLET\TRANDOLAPRIL
SPL Moiety
ORAL\TABLET\TRANDOLAPRIL
ORAL\TABLET\TRANDOLAPRILAT

product(s) by strength(s)

trandolapril 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000742278MavikNDAAbbvie Inc.1996-04-26TRANDOLAPRILORALTABLETNDA0205285ad67ea2-409c-4f52-a9b8-38216209609a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937325ANDATeva Pharmaceuticals Usa Inc2007-02-072016-02-29TRANDOLAPRILORALTABLETANDA07748926404e50-011e-4068-9745-647d2de681a3
2162520541ANDAActavis Pharma, Inc.2007-06-12TRANDOLAPRILORALTABLETANDA077805268fe552-b8f0-45ab-658a-39616c40c9d4
3428060052ANDAEpic Pharma, Llc2015-03-31TRANDOLAPRILORALTABLETANDA07850810f25119-9970-46fe-bf36-6fec6064895b
4572370089ANDACitron Pharma Llc2007-06-12TRANDOLAPRILORALTABLETANDA0784380107d19a-b43a-4a36-8b8c-4dfc247630e9
5658620164ANDAAurobindo Pharma Limited2007-06-12TRANDOLAPRILORALTABLETANDA0784386f25ed16-e5e9-4170-b4b4-3b460887779e
6681800566ANDALupin Pharmaceuticals, Inc.2007-06-11TRANDOLAPRILORALTABLETANDA0775228143a6cf-dadc-4ef7-a8db-d16d7150ad34

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910837ANDAAvkare, Inc.2013-07-30TRANDOLAPRILORALTABLET000937325ANDA07748962a7e612-ced2-7f64-d8c4-76191c2a0fdc
2681510757ANDACarilion Materials Management2007-06-11TRANDOLAPRILORALTABLET681800566ANDA07752294de983f-549b-42ed-9f40-b022aa3bef0f

trandolapril 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000742279MavikNDAAbbvie Inc.1996-04-26TRANDOLAPRILORALTABLETNDA0205285ad67ea2-409c-4f52-a9b8-38216209609a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937326ANDATeva Pharmaceuticals Usa Inc2007-02-072016-03-31TRANDOLAPRILORALTABLETANDA07748926404e50-011e-4068-9745-647d2de681a3
2162520542ANDAActavis Pharma, Inc.2007-06-12TRANDOLAPRILORALTABLETANDA077805268fe552-b8f0-45ab-658a-39616c40c9d4
3428060053ANDAEpic Pharma, Llc2015-03-31TRANDOLAPRILORALTABLETANDA07850810f25119-9970-46fe-bf36-6fec6064895b
4572370090ANDACitron Pharma Llc2007-06-12TRANDOLAPRILORALTABLETANDA0784380107d19a-b43a-4a36-8b8c-4dfc247630e9
5658620165ANDAAurobindo Pharma Limited2007-06-12TRANDOLAPRILORALTABLETANDA0784386f25ed16-e5e9-4170-b4b4-3b460887779e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910838ANDAAvkare, Inc.2013-07-30TRANDOLAPRILORALTABLET000937326ANDA07748962a7e612-ced2-7f64-d8c4-76191c2a0fdc
2681513591ANDACarilion Materials Management2007-02-07TRANDOLAPRILORALTABLET000937326ANDA077489eea9d789-30e2-42fc-8417-59e90648a96b

trandolapril 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000742280MavikNDAAbbvie Inc.1996-04-26TRANDOLAPRILORALTABLETNDA0205285ad67ea2-409c-4f52-a9b8-38216209609a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937327ANDATeva Pharmaceuticals Usa Inc2007-02-072016-08-31TRANDOLAPRILORALTABLETANDA07748926404e50-011e-4068-9745-647d2de681a3
2162520543ANDAActavis Pharma, Inc.2007-06-12TRANDOLAPRILORALTABLETANDA077805268fe552-b8f0-45ab-658a-39616c40c9d4
3428060054ANDAEpic Pharma, Llc2015-03-31TRANDOLAPRILORALTABLETANDA07850810f25119-9970-46fe-bf36-6fec6064895b
4572370091ANDACitron Pharma Llc2007-06-12TRANDOLAPRILORALTABLETANDA0784380107d19a-b43a-4a36-8b8c-4dfc247630e9
5658620166ANDAAurobindo Pharma Limited2007-06-12TRANDOLAPRILORALTABLETANDA0784386f25ed16-e5e9-4170-b4b4-3b460887779e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686061ANDAPhysicians Total Care, Inc.2009-08-26TRANDOLAPRILORALTABLET007815322ANDA077256ad682e7f-e0f5-4f11-8e05-dd308cbf6a05

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910839ANDAAvkare, Inc.2013-07-30TRANDOLAPRILORALTABLET000937327ANDA07748962a7e612-ced2-7f64-d8c4-76191c2a0fdc
2548685099MavikNDAPhysicians Total Care, Inc.2004-06-25TRANDOLAPRILORALTABLET000742280NDA020528bcaffc12-69af-46a8-a092-b3f66a0508d5
3682586100ANDADispensing Solutions, Inc.2007-02-07TRANDOLAPRILORALTABLET000937327ANDA077489ded11cef-9e74-400b-80f4-8947845f5eda

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077256TRANDOLAPRILTrueCOREPHARMA LLC2007-06-12ANDA077256_001, ANDA077256_002, ANDA077256_003
2ANDA077307TRANDOLAPRILTrueCIPLA LTD2007-06-12ANDA077307_001, ANDA077307_002, ANDA077307_003
3ANDA077489TRANDOLAPRILTEVA PHARMACEUTICALS USA2006-12-12ANDA077489_001, ANDA077489_002, ANDA077489_003
4ANDA077522TRANDOLAPRILLUPIN LTD2007-06-12ANDA077522_001, ANDA077522_002, ANDA077522_003
5ANDA077805TRANDOLAPRILWATSON LABORATORIES INC2007-06-12ANDA077805_001, ANDA077805_002, ANDA077805_003
6ANDA078320TRANDOLAPRILINVAGEN PHARMACEUTICALS INC2007-06-12ANDA078320_001, ANDA078320_002, ANDA078320_003
7ANDA078346TRANDOLAPRILMYLAN PHARMACEUTICALS INC2008-04-28ANDA078346_001, ANDA078346_002, ANDA078346_003
8ANDA078438TRANDOLAPRILAUROBINDO PHARMA LTD2007-06-12ANDA078438_001, ANDA078438_002, ANDA078438_003
9ANDA078493TRANDOLAPRILTrueDR REDDYS LABORATORIES LTD2008-08-25ANDA078493_001, ANDA078493_002, ANDA078493_003
10ANDA078508TRANDOLAPRILEPIC PHARMA LLC2008-06-18ANDA078508_001, ANDA078508_002, ANDA078508_003
11NDA020528MAVIKABBVIE INC1996-04-26p5744496, CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)NDA020528_001, NDA020528_002, NDA020528_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077256_001discontinuedTRANDOLAPRIL (1MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
2ANDA077256_002discontinuedTRANDOLAPRIL (2MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
3ANDA077256_003discontinuedTRANDOLAPRIL (4MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
4ANDA077307_001discontinuedTRANDOLAPRIL (2MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
5ANDA077307_002discontinuedTRANDOLAPRIL (1MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
6ANDA077307_003discontinuedTRANDOLAPRIL (4MG)ORALTABLETFalse2007-06-12TRANDOLAPRIL
7ANDA077489_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2006-12-12TRANDOLAPRIL
8ANDA077489_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2006-12-12TRANDOLAPRIL
9ANDA077489_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2006-12-12TRANDOLAPRIL
10ANDA077522_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
11ANDA077522_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
12ANDA077522_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
13ANDA077805_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
14ANDA077805_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
15ANDA077805_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
16ANDA078320_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
17ANDA078320_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
18ANDA078320_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
19ANDA078346_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2008-04-28TRANDOLAPRIL
20ANDA078346_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2008-04-28TRANDOLAPRIL
21ANDA078346_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2008-04-28TRANDOLAPRIL
22ANDA078438_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
23ANDA078438_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
24ANDA078438_003RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2007-06-12TRANDOLAPRIL
25ANDA078493_001discontinuedTRANDOLAPRIL (1MG)ORALTABLETFalse2008-08-25TRANDOLAPRIL
26ANDA078493_002discontinuedTRANDOLAPRIL (2MG)ORALTABLETFalse2008-08-25TRANDOLAPRIL
27ANDA078493_003discontinuedTRANDOLAPRIL (4MG)ORALTABLETFalse2008-08-25TRANDOLAPRIL
28ANDA078508_001RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB2008-06-18TRANDOLAPRIL
29ANDA078508_002RXTRANDOLAPRIL (4MG)ORALTABLETFalseAB2008-06-18TRANDOLAPRIL
30ANDA078508_003RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB2008-06-18TRANDOLAPRIL
31NDA020528_001RXTRANDOLAPRIL (1MG)ORALTABLETFalseAB1996-04-26MAVIK
32NDA020528_002RXTRANDOLAPRIL (2MG)ORALTABLETFalseAB1996-04-26MAVIK
33NDA020528_003RXTRANDOLAPRIL (4MG)ORALTABLETTrueAB1996-04-26MAVIK

patent(s)

#idexpiration dateapplication(s)
1p5744496 (view patent)2015-04-28NDA020528

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10107d19a-b43a-4a36-8b8c-4dfc247630e9 (view SPL)Trandolapril Tablets USPRx onlyprescriptionHuman PrescriptionCitron Pharma Llc2015-08-192572370089, 572370090, 572370091
210f25119-9970-46fe-bf36-6fec6064895b (view SPL)TRANDOLAPRIL TABLETS USPprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-03-314428060052, 428060053, 428060054
326404e50-011e-4068-9745-647d2de681a3 (view SPL)TRANDOLAPRIL TABLETS 732573267327 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-168000937325, 000937326, 000937327
4268fe552-b8f0-45ab-658a-39616c40c9d4 (view SPL)Trandolapril Tablets, USP Rx OnlyprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-06-057162520541, 162520542, 162520543
55ad67ea2-409c-4f52-a9b8-38216209609a (view SPL)MAVIK(trandolapril tablets)prescriptionHuman PrescriptionAbbvie Inc.2015-01-071435000742278, 000742279, 000742280
662a7e612-ced2-7f64-d8c4-76191c2a0fdc (view SPL)TRANDOLAPRIL TABLETSRx onlyprescriptionHuman PrescriptionAvkare, Inc.2013-07-302422910837, 422910838, 422910839
76f25ed16-e5e9-4170-b4b4-3b460887779e (view SPL)Trandolapril Tablets USPprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-1914658620164, 658620165, 658620166
88143a6cf-dadc-4ef7-a8db-d16d7150ad34 (view SPL)TRANDOLAPRIL TABLETS USP1 mg, 2 mg and 4 mgRx onlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-07-275681800566
994de983f-549b-42ed-9f40-b022aa3bef0f (view SPL)TRANDOLAPRIL TABLETS USP 1 mg, 2 mg and 4 mg Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-12-202681510757
10ad682e7f-e0f5-4f11-8e05-dd308cbf6a05 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-091548686061
11bcaffc12-69af-46a8-a092-b3f66a0508d5 (view SPL)MAVIK(trandolapril tablets)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-142548685099
12ded11cef-9e74-400b-80f4-8947845f5eda (view SPL)TRANDOLAPRIL TABLETS732573267327Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-10-244682586100
13eea9d789-30e2-42fc-8417-59e90648a96b (view SPL)TRANDOLAPRIL TABLETS 7325 7326 7327 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-11-212681513591

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