Hydrochlorothiazide / irbesartan Oral Tablet

Brand(s)
Avalide
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-10-02)
Oldest Current Product
1997-09-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:IRBESARTAN
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: IRBESARTAN
SPL Active
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: IRBESARTAN
ORAL\TABLET\HYDROCHLOROTHIAZIDE: IRBESARTAN
SPL Moiety
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: IRBESARTAN
ORAL\TABLET\HYDROCHLOROTHIAZIDE: IRBESARTAN

product(s) by strength(s)

hydrochlorothiazide 12.5 mg / irbesartan 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000245855AvalideNDASanofi-Aventis U.S. Llc2013-01-01HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDNDA0207580d91895e-c869-4b33-9b83-d55c1ad6317e
2000872875AvalideNDABristol-Myers Squibb Company2011-02-252015-08-31HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDNDA0207589ac8b9fe-dfb9-0151-30b3-f9da72d74ac2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540254ANDARoxane Laboratories, Inc2012-10-15HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA09035117561aae-f0bc-4ffc-a007-985b17e9baf0
2000938238ANDATeva Pharmaceuticals Usa Inc2013-01-24HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA07736983f4acc1-697a-4770-b554-1b9a8fb5de74
3003783033ANDAMylan Pharmaceuticals Inc.2012-09-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA07796954c6490a-288e-4fa9-2300-c6d37cf61604
4005912785ANDAWatson Laboratories, Inc.2012-10-22HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA091539eadf250d-3869-5a67-0678-e3dd63d6bc3f
5006034088ANDAQualitest Pharmaceuticals2012-09-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA0913700d3df019-85ec-47c3-bb35-f1fa36326392
6333420057ANDAMacleods Pharmaceuticals Limited2012-09-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA2024141898f438-4571-4aab-ae06-9bf1aabf0486
7435470330ANDASolco Healthcare U.S., Llc2014-03-01HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA20307272fa8cd4-bc2a-4a7d-8feb-2d60e077d801
8605053603ANDAApotex Corp2012-10-16HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA201505d94aac52-8a26-782c-fecc-3a20e926c33e
9658620629ANDAAurobindo Pharma Limited2013-02-22HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA203630466dd0d2-9815-4c3e-b66b-d0732b3ba8e9
10681800413ANDALupin Pharmaceuticals, Inc.2013-04-04HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA201524599548e1-5879-4160-871a-b8c3f6e19652

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910342ANDAAvkare, Inc.2013-09-26HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000938238ANDA077369abb6d618-dce2-3169-d401-2da7e412ca6f
2548684494AvalideNDAPhysicians Total Care, Inc.2001-05-17HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000872775NDA020758c7750b68-b3d8-45fa-b134-bf75f6ac510e
3548686457ANDAPhysicians Total Care, Inc.2012-09-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATED333420057ANDA202414f5b37c13-e10c-4623-aac5-9a6512b2f701
4551542023AvalideNDACardinal Health1997-09-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000872775NDA020758716ab835-584e-4bdc-ac7c-f685d88b4dad
5551542027AvalideNDACardinal Health2011-02-25HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATED000872875NDA0207584728ab46-ad9b-4fd9-a8bd-9f51ffa84127
6686450405ANDALegacy Pharmaceutical Packaging, Llc2012-03-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000937238ANDA0773692f29f67a-2918-4318-9cb1-5e0eb22b35a3

hydrochlorothiazide 12.5 mg / irbesartan 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000245856AvalideNDASanofi-Aventis U.S. Llc2013-01-01HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDNDA0207580d91895e-c869-4b33-9b83-d55c1ad6317e
2000872776AvalideNDABristol-Myers Squibb Company1998-08-312014-06-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETNDA0207589ac8b9fe-dfb9-0151-30b3-f9da72d74ac2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540255ANDARoxane Laboratories, Inc2012-10-15HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA09035117561aae-f0bc-4ffc-a007-985b17e9baf0
2000938232ANDATeva Pharmaceuticals Usa Inc2013-08-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA07736983f4acc1-697a-4770-b554-1b9a8fb5de74
3003783034ANDAMylan Pharmaceuticals Inc.2012-09-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA07796954c6490a-288e-4fa9-2300-c6d37cf61604
4005912786ANDAWatson Laboratories, Inc.2012-10-22HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA091539eadf250d-3869-5a67-0678-e3dd63d6bc3f
5006034089ANDAQualitest Pharmaceuticals2012-09-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA0913700d3df019-85ec-47c3-bb35-f1fa36326392
6333420058ANDAMacleods Pharmaceuticals Limited2012-09-27HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA2024141898f438-4571-4aab-ae06-9bf1aabf0486
7435470331ANDASolco Healthcare U.S., Llc2014-03-01HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLETANDA20307272fa8cd4-bc2a-4a7d-8feb-2d60e077d801
8605053604ANDAApotex Corp2012-10-16HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA201505d94aac52-8a26-782c-fecc-3a20e926c33e
9658620630ANDAAurobindo Pharma Limited2013-02-22HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDANDA203630466dd0d2-9815-4c3e-b66b-d0732b3ba8e9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910343ANDAAvkare, Inc.2013-09-26HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000938232ANDA077369abb6d618-dce2-3169-d401-2da7e412ca6f
2548684526AvalideNDAPhysicians Total Care, Inc.2004-09-08HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000872776NDA020758c7750b68-b3d8-45fa-b134-bf75f6ac510e
3551542024AvalideNDACardinal Health1998-08-31HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET000872776NDA020758716ab835-584e-4bdc-ac7c-f685d88b4dad
4551542028AvalideNDACardinal Health2011-02-24HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATED000872876NDA0207584728ab46-ad9b-4fd9-a8bd-9f51ffa84127

hydrochlorothiazide 25 mg / irbesartan 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000872788AvalideNDABristol-Myers Squibb Company2005-03-152013-11-30HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATEDNDA0207589ac8b9fe-dfb9-0151-30b3-f9da72d74ac2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685465AvalideNDAPhysicians Total Care, Inc.2005-11-01HYDROCHLOROTHIAZIDE, IRBESARTANORALTABLET, FILM COATED000872788NDA020758c7750b68-b3d8-45fa-b134-bf75f6ac510e

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077369IRBESARTAN AND HYDROCHLOROTHIAZIDETEVA PHARMACEUTICALS USA INC2012-03-30ANDA077369_001, ANDA077369_002, ANDA077369_003
2ANDA077446IRBESARTAN AND HYDROCHLOROTHIAZIDESANDOZ INC2012-09-27ANDA077446_001, ANDA077446_002
3ANDA077969IRBESARTAN AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC2012-09-27ANDA077969_001, ANDA077969_002
4ANDA090351IRBESARTAN AND HYDROCHLOROTHIAZIDEROXANE LABORATORIES INC2012-10-15ANDA090351_001, ANDA090351_002
5ANDA091370IRBESARTAN AND HYDROCHLOROTHIAZIDEALEMBIC LTD2012-10-15ANDA091370_001, ANDA091370_002
6ANDA091539IRBESARTAN AND HYDROCHLOROTHIAZIDEWATSON LABORATORIES INC2012-10-22ANDA091539_001, ANDA091539_002
7ANDA201505IRBESARTAN AND HYDROCHLOROTHIAZIDEAPOTEX INC2012-10-15ANDA201505_001, ANDA201505_002
8ANDA201524IRBESARTAN AND HYDROCHLOROTHIAZIDELUPIN LTD2013-02-27ANDA201524_001, ANDA201524_002
9ANDA202414IRBESARTAN AND HYDROCHLOROTHIAZIDEMACLEODS PHARMACEUTICALS LTD2012-09-27ANDA202414_001, ANDA202414_002
10ANDA203072IRBESARTAN AND HYDROCHLOROTHIAZIDEPRINSTON PHARMACEUTICAL INC2014-05-09ANDA203072_001, ANDA203072_002
11ANDA203500IRBESARTAN AND HYDROCHLOROTHIAZIDEDR REDDYS LABORATORIES LTD2012-09-27ANDA203500_001, ANDA203500_002
12ANDA203630IRBESARTAN AND HYDROCHLOROTHIAZIDEAUROBINDO PHARMA LTD2013-02-22ANDA203630_001, ANDA203630_002
13NDA020758AVALIDESANOFI AVENTIS US LLC1997-09-30p5994348, SUBSTANCENDA020758_001, NDA020758_002, NDA020758_003, NDA020758_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077369_001RXIRBESARTAN (150MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-03-30IRBESARTAN AND HYDROCHLOROTHIAZIDE
2ANDA077369_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2012-03-30IRBESARTAN AND HYDROCHLOROTHIAZIDE
3ANDA077369_003discontinuedHYDROCHLOROTHIAZIDE (25MG), IRBESARTAN (300MG)ORALTABLETFalse2012-03-30IRBESARTAN AND HYDROCHLOROTHIAZIDE
4ANDA077446_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
5ANDA077446_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
6ANDA077969_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
7ANDA077969_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
8ANDA090351_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
9ANDA090351_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
10ANDA091370_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
11ANDA091370_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
12ANDA091539_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-10-22IRBESARTAN AND HYDROCHLOROTHIAZIDE
13ANDA091539_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2012-10-22IRBESARTAN AND HYDROCHLOROTHIAZIDE
14ANDA201505_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
15ANDA201505_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2012-10-15IRBESARTAN AND HYDROCHLOROTHIAZIDE
16ANDA201524_001RXIRBESARTAN (150MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2013-02-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
17ANDA201524_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2013-02-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
18ANDA202414_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
19ANDA202414_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
20ANDA203072_001RXIRBESARTAN (150MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2014-05-09IRBESARTAN AND HYDROCHLOROTHIAZIDE
21ANDA203072_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (300MG)ORALTABLETFalseAB2014-05-09IRBESARTAN AND HYDROCHLOROTHIAZIDE
22ANDA203500_001RXIRBESARTAN (150MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
23ANDA203500_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-09-27IRBESARTAN AND HYDROCHLOROTHIAZIDE
24ANDA203630_001RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETFalseAB2013-02-22IRBESARTAN AND HYDROCHLOROTHIAZIDE
25ANDA203630_002RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2013-02-22IRBESARTAN AND HYDROCHLOROTHIAZIDE
26NDA020758_001discontinuedIRBESARTAN (75MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalse1997-09-30AVALIDE
27NDA020758_002RXHYDROCHLOROTHIAZIDE (12.5MG), IRBESARTAN (150MG)ORALTABLETTrueAB1997-09-30AVALIDE
28NDA020758_003RXIRBESARTAN (300MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETTrueAB1998-08-31AVALIDE
29NDA020758_004discontinuedHYDROCHLOROTHIAZIDE (25MG), IRBESARTAN (300MG)ORALTABLETFalse2005-03-15AVALIDE

patent(s)

#idexpiration dateapplication(s)
1p5994348 (view patent)2015-06-07NDA020758

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10d3df019-85ec-47c3-bb35-f1fa36326392 (view SPL)These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets safely and effectively.See full prescribing information for Irbesartan and Hydrochlorothiazide TabletsIrbesartan and Hydrochlorothiazide Tablets, for oral use.Initial U.S. Approval: 1997prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-03-118006034088, 006034089
20d91895e-c869-4b33-9b83-d55c1ad6317e (view SPL)These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-10-024000245855, 000245856
317561aae-f0bc-4ffc-a007-985b17e9baf0 (view SPL)These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, USP safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, USP.IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-07-282000540254, 000540255
41898f438-4571-4aab-ae06-9bf1aabf0486 (view SPL)These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2014-06-305333420057, 333420058
52f29f67a-2918-4318-9cb1-5e0eb22b35a3 (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionLegacy Pharmaceutical Packaging, Llc2012-10-054686450405
6466dd0d2-9815-4c3e-b66b-d0732b3ba8e9 (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets, USP. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-06-182658620629, 658620630
74728ab46-ad9b-4fd9-a8bd-9f51ffa84127 (view SPL)These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionCardinal HealthREPACK2012-05-091551542027, 551542028
854c6490a-288e-4fa9-2300-c6d37cf61604 (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-02-108003783033, 003783034
9599548e1-5879-4160-871a-b8c3f6e19652 (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets.Irbesartan and Hydrochlorothiazide Tablets USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2014-08-016681800413
10716ab835-584e-4bdc-ac7c-f685d88b4dad (view SPL)These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionCardinal HealthREPACK2010-12-101551542023, 551542024
1172fa8cd4-bc2a-4a7d-8feb-2d60e077d801 (view SPL)These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets. Irbesartan and Hydrochlorothiazide Tablets, USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionSolco Healthcare U.S., Llc2014-11-012435470330, 435470331
1283f4acc1-697a-4770-b554-1b9a8fb5de74 (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-244000938232, 000938238
139ac8b9fe-dfb9-0151-30b3-f9da72d74ac2 (view SPL)These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionBristol-Myers Squibb Company2012-10-2612000872776, 000872788, 000872875, 000872775, 000872876
14abb6d618-dce2-3169-d401-2da7e412ca6f (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAvkare, Inc.2013-09-262422910342, 422910343
15c7750b68-b3d8-45fa-b134-bf75f6ac510e (view SPL)These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-192548684494, 548684526, 548685465
16d94aac52-8a26-782c-fecc-3a20e926c33e (view SPL)These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE tablets safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE tablets. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-07-015605053603, 605053604
17eadf250d-3869-5a67-0678-e3dd63d6bc3f (view SPL)These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-09-016005912785, 005912786
18f5b37c13-e10c-4623-aac5-9a6512b2f701 (view SPL)These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2015-05-072548686457

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