Application 087562

Type
ANDA
Sponsor
IDT AUSTRALIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPYRIDAMOLEDIPYRIDAMOLETABLET;ORAL50MGNoNo

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 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DipyridamoleDIPYRIDAMOLEHikma Pharmaceuticals USA Inc.6093dcd9-82d2-414f-8507-eda22c14f6262026-05-20Warnings, Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEREMEDYREPACK INC.226099e2-70bb-4b9b-bb52-c20fbca2aec52026-04-29Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEAmneal Pharmaceuticals of New York LLCa18b2af5-7c4a-4b7f-92c7-8a76e34da3732026-04-15Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEHenry Schein, Inc.1a2c0a9a-c637-4485-ad4b-0b6d0b05fa202025-10-30Warnings, Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DIPYRIDAMOLEDIPYRIDAMOLEHF Acquisition Co LLC, DBA HealthFirst9bd34108-9d98-c4ca-e053-2995a90a2bc82025-01-08Warnings, Adverse reactionsName fallback
brand name: DIPYRIDAMOLE
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEZydus Lifesciences Limited312aadb1-435c-4aa7-8e46-6506cedacaa02024-11-26Name fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEZydus Pharmaceuticals USA Inc.004bada0-dbf7-4a94-8792-6833d7eeda2b2023-09-16Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE
DipyridamoleDIPYRIDAMOLEOxford Pharmaceuticals, LLCf7ffd78a-e93a-40f4-8193-2d6ab4dafd002021-03-29Adverse reactionsName fallback
brand name: Dipyridamole
generic name: DIPYRIDAMOLE

Reported adverse events (FAERS/openFDA)#

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