FDA.reportPublic FDA data

Application 211361

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMNoNo

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
A211361-001RANOLAZINERANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2025-04-15
A211361-002RANOLAZINERANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2025-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211361-001AB
A211361-002AB

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 UTC2026-02A211361-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211361-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2025-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211361-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211361-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2025-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211361-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211361-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2025-04-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211361-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211361-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2025-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211361-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211361-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211361-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211361-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211361-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211361-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211361-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211361-002AB1a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanolazineRANOLAZINEMajor Pharmaceuticals6166c40c-4fbe-47c4-92e4-2dc5d3567a862026-06-09Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINELifestar Pharma LLC195c4b51-fec2-410d-8d90-487c536a87282026-05-06Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEZameer Pharmaceuticals LLC5f4fc8a4-2bd5-4378-8882-e739c951390e2026-04-21Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINETorrent Pharma, Inc.d2454377-2abd-4d9f-85f1-12f1adbb10e52026-04-15Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINESunGen Pharma LLCf3c09979-a44a-4197-97d2-29a207b6fc732026-03-25Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RANOLAZINERANOLAZINERadha Pharmaceuticals, Inc38d2833d-44b8-8d46-e063-6394a90a74d82026-02-20Warnings, Adverse reactionsName fallback
brand name: RANOLAZINE
generic name: RANOLAZINE
RanolazineRANOLAZINEZydus Lifesciences Limitedd74f3dea-7357-4e9a-be9a-2f498a44108a2026-01-29Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEViona Pharmaceuticals Inc00979fb3-d70f-493d-94ca-2914cbadaa9d2026-01-29Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEGlenmark Pharmaceuticals Inc., USA0cf58732-c242-49b0-8e3f-248778b4458d2026-01-23Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINENCS HealthCare of KY, LLC dba Vangard Labs2373687b-b9a4-496e-b89f-9754f8513fd32026-01-21Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEAvKAREb2a8dc3e-a880-5241-e053-2995a90a933a2026-01-15Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEAvPAKe92350e8-5b0b-95d3-e053-2995a90a959b2026-01-09Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RANOLAZINERANOLAZINEAphena Pharma Solutions - Tennessee, LLC45236b7d-3728-1e13-e063-6394a90ad77f2025-12-04Warnings, Adverse reactionsName fallback
brand name: RANOLAZINE
generic name: RANOLAZINE
RanolazineRANOLAZINEAjanta Pharma USA Inc.8bfd1a61-547a-4847-ae4e-480b17da62722025-10-28Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEAscend Laboratories, LLC5b254a8e-db88-49be-bb48-e6d2847f8ab32025-07-28Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RANOLAZINERANOLAZINEA2A Integrated Pharmaceuticals9fb62878-c76a-4be2-99be-962ce2956af22025-02-28Warnings, Adverse reactionsName fallback
brand name: RANOLAZINE
generic name: RANOLAZINE
ASPRUZYO SPRINKLERANOLAZINESUN PHARMACEUTICAL INDUSTRIES, INC.dd9f81e4-50da-4551-aed5-559d304df42e2025-01-29Warnings, Adverse reactionsName fallback
generic name: RANOLAZINE
RANOLAZINERANOLAZINEBryant Ranch Prepack9199e28a-ddbe-46a4-ab26-9b08034289be2025-01-23Warnings, Adverse reactionsName fallback
brand name: RANOLAZINE
generic name: RANOLAZINE
RanolazineRANOLAZINEBryant Ranch Prepack2e678c80-1410-433b-8c48-4b210eceb0de2025-01-17Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RANOLAZINERANOLAZINEScieGen Pharmaceuticals, Inc71d50258-75b7-4801-b0f4-c34fe883d57d2024-12-24Warnings, Adverse reactionsName fallback
brand name: RANOLAZINE
generic name: RANOLAZINE