FDA.reportPublic FDA data

Application 079238

Type
ANDA
Sponsor
PLIVA HRVATSKA DOO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARGATROBANARGATROBANINJECTABLE; INJECTION100MGNoNo

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 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArgatrobanARGATROBANPlano Pharmaceuticals Inc.514ad15b-d060-9d65-e063-6294a90a61882026-07-29Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANMullan Pharmaceutical Inc.546484ed-afab-b47b-e063-6394a90aa52d2026-06-16Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANMullan Pharmaceutical Inc.50e21062-f021-40f2-ad11-896f46378a152026-06-15Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANGland Pharma Limited270dbb59-e080-4a64-91d9-a68bed4bd2e52026-06-09Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ARGATROBANARGATROBANAccord Healthcare Inc.46cdf9e6-839c-49c8-9ee1-c30cfdd9368d2026-05-21Warnings, Adverse reactionsName fallback
brand name: ARGATROBAN
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.0cdf3f67-5bf3-4d58-b330-03febdc652bf2026-05-03Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ARGATROBANARGATROBANCaplin Steriles Limitedb5143563-ff45-433a-a9e2-f8b8340db1f52026-04-17Warnings, Adverse reactionsName fallback
brand name: ARGATROBAN
generic name: ARGATROBAN
ArgatrobanARGATROBANGland Pharma Limitede5ccb93c-f411-4e7e-824a-4a592b4947ec2026-03-17Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANFresenius Kabi USA, LLCdfa5d325-f609-4c9a-aaae-1a17df47da1e2025-09-03Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANMylan Institutional LLCb0dedf95-8395-46bf-b94a-dcf2dd0859422025-08-15Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.41f56fe7-4824-4032-aa73-cfb4f8db22522024-04-11Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.79eec27d-ac63-4996-8b1a-c2cd52ad2b2c2024-04-11Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANEugia US LLCd9b975bd-e3f4-466e-96ca-7bef7899506d2023-08-03Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANPar Health USA, LLC1a67a87d-59cb-414c-a11e-ab8f0a9bb7782023-08-01Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANPar Health USA, LLCd4e5238f-2378-424e-bda2-f1a2cf8740412023-08-01Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANSagent Pharmaceuticals629aee90-3bf3-4947-a978-21cbba2e1c412021-03-03Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN
ArgatrobanARGATROBANAmneal Pharmaceuticals LLCdedef330-555a-46b7-b1d6-0838b4cd96512019-05-23Warnings, Adverse reactionsName fallback
brand name: Argatroban
generic name: ARGATROBAN