FDA.reportPublic FDA data

Application 208174

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL1000MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanolazineRANOLAZINEAmerican Health Packaging90c5a0c2-542c-467e-9c0c-ef320534c5602026-08-19Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
RanolazineRANOLAZINEUmedica Laboratories USA Inc.a624dc7f-921d-4554-a813-f72dca0133c32026-08-07Warnings, Adverse reactionsName fallback
brand name: Ranolazine
generic name: RANOLAZINE
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
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

Reported adverse events (FAERS/openFDA)#

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