FDA.reportPublic FDA data

Application 077483

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGNoNo
002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGNoNo
003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGNoNo
004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-08
A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-08
A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-08
A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-08

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077483-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2005-09-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077483-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2005-09-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077483-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2005-09-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077483-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2005-09-084b0b4de00fa7…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEAdvagen Pharma Ltd3f6e6da8-6da3-47c5-a151-e6fd7206890e2026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: benazepril hydrochloride and hydrochlorothiazide
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.e6527adf-8c74-4d81-9199-d56a7fca895e2025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride and Hydrochlorothiazide
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDESandoz Incc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f2025-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride and Hydrochlorothiazide
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf4120568-dd9b-47a5-bd44-4de6ed343bbe2024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: benazepril hydrochloride and hydrochlorothiazide
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA51b0aed8-a229-4d2c-8fdf-aa957fddc41b2023-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride and Hydrochlorothiazide
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPadagis US LLC3e2d3974-38b0-49d0-8020-f741075847242023-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: benazepril hydrochloride and hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63304-154Benazepril hydrochloride and hydrochlorothiazideBenazepril hydrochloride and hydrochlorothiazideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-155Benazepril hydrochloride and hydrochlorothiazideBenazepril hydrochloride and hydrochlorothiazideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-156Benazepril hydrochloride and hydrochlorothiazideBenazepril hydrochloride and hydrochlorothiazideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-157Benazepril hydrochloride and hydrochlorothiazideBenazepril hydrochloride and hydrochlorothiazideRanbaxy Pharmaceuticals Inc.ANDACurrent