FDA.reportPublic FDA data

Application 215238

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215238-001IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-08
A215238-002IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215238-001AB
A215238-002AB

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
2026-02-19 14:30 UTC2026-02A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-082680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215238-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2024-11-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215238-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2024-11-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215238-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215238-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215238-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215238-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215238-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215238-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215238-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215238-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215238-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215238-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215238-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215238-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215238-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215238-002AB12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215238-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215238-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvabradineIVABRADINEAlembic Pharmaceuticals Limited51ac7345-3188-4382-ab1d-9120d6c889272024-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215238
application number: ANDA215238
IvabradineIVABRADINEAlembic Pharmaceuticals Inc.53f15531-796d-442b-a73c-05f0482185312024-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215238
application number: ANDA215238

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71924ORIG2022-08-26