FDA.reportPublic FDA data

Application 201743

Type
NDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARGATROBAN IN DEXTROSEARGATROBANSOLUTION;INTRAVENOUS125MG/125ML (1MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201743-001ARGATROBAN IN DEXTROSEARGATROBAN125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUS2011-05-09

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N201743-001ARGATROBAN IN DEXTROSE125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUS2011-05-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N201743-001ARGATROBAN IN DEXTROSE125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUS2011-05-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N201743-001ARGATROBAN IN DEXTROSE125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUS2011-05-09a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArgatrobanARGATROBANPar Health USA, LLC1a67a87d-59cb-414c-a11e-ab8f0a9bb7782026-08-20Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANPar Health USA, LLCd4e5238f-2378-424e-bda2-f1a2cf8740412026-08-19Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANSagent Pharmaceuticals629aee90-3bf3-4947-a978-21cbba2e1c412026-07-29Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANMullan Pharmaceutical Inc.546484ed-afab-b47b-e063-6394a90aa52d2026-06-16Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANMullan Pharmaceutical Inc.50e21062-f021-40f2-ad11-896f46378a152026-06-15Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANGland Pharma Limited270dbb59-e080-4a64-91d9-a68bed4bd2e52026-06-09Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ARGATROBANARGATROBANAccord Healthcare Inc.46cdf9e6-839c-49c8-9ee1-c30cfdd9368d2026-05-21Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.0cdf3f67-5bf3-4d58-b330-03febdc652bf2026-05-03Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ARGATROBANARGATROBANCaplin Steriles Limitedb5143563-ff45-433a-a9e2-f8b8340db1f52026-04-17Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANGland Pharma Limitede5ccb93c-f411-4e7e-824a-4a592b4947ec2026-03-17Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANFresenius Kabi USA, LLCdfa5d325-f609-4c9a-aaae-1a17df47da1e2025-09-03Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANMylan Institutional LLCb0dedf95-8395-46bf-b94a-dcf2dd0859422025-08-15Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.41f56fe7-4824-4032-aa73-cfb4f8db22522024-04-11Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANHikma Pharmaceuticals USA Inc.79eec27d-ac63-4996-8b1a-c2cd52ad2b2c2024-04-11Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANEugia US LLCd9b975bd-e3f4-466e-96ca-7bef7899506d2023-08-03Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN
ArgatrobanARGATROBANAmneal Pharmaceuticals LLCdedef330-555a-46b7-b1d6-0838b4cd96512019-05-23Warnings, Adverse reactionsName fallback
generic name: ARGATROBAN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54855SUPPL2018-07-06
54718SUPPL2018-06-28
19034SUPPL2016-06-01
9929SUPPL2016-05-27
24401ORIG2012-01-05
22856ORIG2012-01-05
32135ORIG2011-05-12
40085ORIG2011-05-09
9928ORIG2011-02-14