FDA.reportPublic FDA data

Application 209591

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;20MGNoNo
002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;40MGNoNo
003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;20MGNoNo
004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;40MGNoNo

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
A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14
A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14
A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14
A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209591-001AB
A209591-002AB
A209591-003AB
A209591-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2025-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209591-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209591-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A209591-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209591-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209591-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209591-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209591-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209591-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209591-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209591-004AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209591-004AB1a50c72e98297…

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
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.99865c67-5475-4e60-98d5-a8fa850fe9ba2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209591
application number: ANDA209591

Reported adverse events (FAERS/openFDA)#

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