Application 020758

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGYesYes
003AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGYesYes
004AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020758-001AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30
N020758-002AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30
N020758-003AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31
N020758-004AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTAN25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020758-002AB
N020758-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-001AVALIDE12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-002AVALIDE12.5MG;150MGTABLET / ORALABRLD, RS1997-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-003AVALIDE12.5MG;300MGTABLET / ORALABRLD, RS1998-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-004AVALIDE25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2005-03-15d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020758-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020758-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020758-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020758-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020758-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020758-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020758-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020758-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020758-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020758-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020758-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020758-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020758-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020758-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020758-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020758-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020758-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020758-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020758-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020758-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020758-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020758-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020758-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020758-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020758-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020758-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020758-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020758-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020758-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020758-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020758-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020758-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020758-003AB1bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvalideIRBESARTAN AND HYDROCHLOROTHIAZIDESanofi-Aventis U.S. LLC0d91895e-c869-4b33-9b83-d55c1ad6317e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020758
application number: NDA020758
ndc (product): 0024-5855
ndc (product): 0024-5856

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5855Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
71335-1392Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1392Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83043SUPPL 2025-08-05
83034SUPPL 2025-08-04
68611SUPPL2021-09-14
68601SUPPL2021-09-13
67468SUPPL2021-05-12
67458SUPPL2021-05-12
65655SUPPL2020-12-21
65601SUPPL2020-12-16
64432SUPPL2020-08-27
64431SUPPL2020-08-27
64384SUPPL2020-08-24
55141SUPPL2018-08-09
54947SUPPL2018-07-23
48972SUPPL2017-07-13
48965SUPPL2017-07-13
35288SUPPL2016-02-18
25721SUPPL2016-02-09
3279SUPPL2014-06-02
35287SUPPL2014-05-30
3278SUPPL2012-10-29
13355SUPPL2012-10-26
35285SUPPL2012-02-17
25719SUPPL2012-02-13
35286SUPPL2012-01-23
25720SUPPL2012-01-23
25718SUPPL2011-06-09
3277SUPPL2011-06-09
35284SUPPL2011-06-06
35283SUPPL2011-06-06
35282SUPPL2010-09-10
25717SUPPL2010-09-09
20913ORIG2009-09-01
25716SUPPL2007-11-19
13354SUPPL2007-11-19
35281SUPPL2006-04-25
3276SUPPL2006-04-25
25715SUPPL2005-11-30
44463SUPPL2005-05-05
41665SUPPL2005-05-05
44464SUPPL2005-05-03
41666SUPPL2005-05-03
20916SUPPL2005-05-03
41667SUPPL2005-04-27
20917SUPPL2005-04-27
3275SUPPL2005-03-18
20915SUPPL2004-05-27
20914SUPPL1998-08-31