Application 207807

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

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
A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-05
A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-05
A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-05
A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-05

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 22:38:342026-08A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORALAB2017-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORALAB2017-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORALAB2017-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORALAB2017-07-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207807-004AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207807-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207807-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207807-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207807-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207807-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207807-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207807-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207807-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207807-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207807-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207807-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207807-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207807-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207807-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207807-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207807-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207807-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207807-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207807-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207807-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207807-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207807-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207807-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207807-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207807-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207807-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207807-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207807-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207807-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207807-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207807-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207807-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207807-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207807-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207807-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207807-004AB1bb7c543d1eb4…

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 MEDOXOMILGlenmark Pharmaceuticals Inc., USA2edf43fb-0755-4ffb-bc38-75a4e24325882021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207807
application number: ANDA207807
ndc (product): 68462-567
ndc (product): 68462-569
ndc (product): 68462-566
ndc (product): 68462-568

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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-923Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomilmedsource pharmaceuticalsANDACurrent
45865-935Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomilmedsource pharmaceuticalsANDACurrent
45865-947Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomilmedsource pharmaceuticalsANDACurrent
60505-4582Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilApotex Corp.ANDACurrent
60505-4583Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilApotex Corp.ANDACurrent
60505-4584Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilApotex Corp.ANDACurrent
60505-4585Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilApotex Corp.ANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-566Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-567Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-568Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-569Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USAANDACurrent