FDA.reportPublic FDA data

Application 091206

Type
ANDA
Sponsor
PLIVA HRVATSKA DOO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIVALIRUDINBIVALIRUDININJECTABLE;INTRAVENOUS250MG/VIALNoNo

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 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINMAIA Pharmaceuticals, Inc.c727199d-f4cd-4658-8fdf-568590beface2024-05-27Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.26fb46f6-0088-42b8-b6f2-c672247768032024-04-04Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINPar Health USA, LLC91cf9d00-29e0-4357-a184-f70026c47edb2024-03-01Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINAvenacy, Inc.42aa2630-83d6-433d-8277-0f672cf8d71d2023-10-20Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINSlate Run Pharmaceuticals, LLC5d9a45c6-e234-4d56-9132-5e24e65852e62021-06-09Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.4119b710-ef30-4e3e-b99a-38e42b4b3fca2021-06-08Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINSandoz Incce56f806-7845-429d-a1ce-c2dbf79b22eb2019-09-30Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINDr. Reddy's Laboratories Limited19beb2ae-6064-3c24-fe50-0cee868969792019-07-16Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN