FDA.reportPublic FDA data

Application 213483

Type
ANDA
Sponsor
MSN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
002IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDETABLET;ORALEQ 7.5MG BASENoNo

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
A213483-001IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2025-04-28
A213483-002IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2025-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213483-001AB
A213483-002AB

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 UTC2026-02A213483-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2025-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213483-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2025-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213483-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2025-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213483-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2025-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213483-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2025-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213483-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2025-04-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213483-001IVABRADINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2025-04-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213483-002IVABRADINE HYDROCHLORIDEEQ 7.5MG BASETABLET / ORALAB2025-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213483-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213483-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213483-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213483-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213483-002AB1a50c72e98297…

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
IvabradineIVABRADINENorthstar Rx LLC5157767b-16d5-4a69-b6bd-95d360d19fda2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213483
application number: ANDA213483
IvabradineIVABRADINENovadoz Pharmaceuticals LLC676907d3-b374-4baa-8422-c047064095402025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213483
application number: ANDA213483