FDA.reportPublic FDA data

Application 202223

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTANVALSARTANTABLET;ORAL40MGNoNo
002VALSARTANVALSARTANTABLET;ORAL80MGNoNo
003VALSARTANVALSARTANTABLET;ORAL160MGNoNo
004VALSARTANVALSARTANTABLET;ORAL320MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202223-001VALSARTANVALSARTAN40MGTABLET / ORALAB2015-01-05
A202223-002VALSARTANVALSARTAN80MGTABLET / ORALAB2015-01-05
A202223-003VALSARTANVALSARTAN160MGTABLET / ORALAB2015-01-05
A202223-004VALSARTANVALSARTAN320MGTABLET / ORALAB2015-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A202223-001AB
A202223-002AB
A202223-003AB
A202223-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-08-18 06:07:402026-07A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202223-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202223-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202223-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202223-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202223-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202223-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202223-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202223-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202223-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202223-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202223-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202223-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202223-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202223-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202223-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202223-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202223-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202223-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202223-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202223-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202223-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202223-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202223-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202223-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202223-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202223-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202223-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202223-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202223-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202223-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202223-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202223-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202223-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202223-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202223-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202223-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202223-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202223-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202223-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202223-004AB174a2ff9319b5…

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
ValsartanVALSARTANAurobindo Pharma Limiteda81a72dd-e828-4208-af9b-bb9ac49385372024-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202223
application number: ANDA202223
ndc (product): 65862-573
ndc (product): 65862-572
ndc (product): 65862-570
ndc (product): 65862-571

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 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2518ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2518ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2518ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2550ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2550ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2550ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2877ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2877ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-2877ValsartanValsartanA-S Medication SolutionsANDACurrent
52343-122ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-122ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-123ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-123ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-124ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-124ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-125ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
52343-125ValsartanvalsartanACETRIS HEALTH, LLCANDACurrent
55154-4676ValsartanValsartanCardinal HealthANDACurrent
55154-4676ValsartanValsartanCardinal HealthANDACurrent
55154-4676ValsartanValsartanCardinal HealthANDACurrent
55154-4678ValsartanValsartanCardinal HealthANDACurrent
55154-4678ValsartanValsartanCardinal HealthANDACurrent
60687-128ValsartanValsartanAmerican Health PackagingANDACurrent
60687-128ValsartanValsartanAmerican Health PackagingANDACurrent
60687-128ValsartanValsartanAmerican Health PackagingANDACurrent
60687-139ValsartanValsartanAmerican Health PackagingANDACurrent
60687-139ValsartanValsartanAmerican Health PackagingANDACurrent
60687-139ValsartanValsartanAmerican Health PackagingANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-570ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-571ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-572ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
65862-573ValsartanValsartanAurobindo Pharma LimitedANDACurrent
70518-0069ValsartanValsartanREMEDYREPACK INC.ANDACurrent
70518-2307ValsartanValsartanREMEDYREPACK INC.ANDACurrent