Active ingredient
Argatroban
18 finished FDA listings contain Argatroban as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ARGATROBAN
- Dosage forms
- Injection, Injection, Solution, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 12
- Strengths listed
- 1 mg/ml · 100 mg/ml · 125 mg/125ml · 250 mg/2.5ml · 50 mg/50ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 15202
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022485 | PLANO PHARMS | 2011-05-09 | 1 |
| NDA 203049 | HIKMA PHARM CO LTD | 2012-01-05 | 4 |
| ANDA 202626 | MYLAN INSTITUTIONAL | 2014-06-30 | 1 |
| ANDA 091665 | PH HEALTH | 2014-06-30 | 2 |
| ANDA 205570 | GLAND | 2017-05-22 | 1 |
| ANDA 206698 | AMNEAL PHARMS CO | 2018-01-26 | 1 |
| NDA 209552 | EUGIA PHARMA SPECLTS | 2018-11-27 | 1 |
| ANDA 214235 | CAPLIN | 2021-01-21 | 3 |
| NDA 212035 | ACCORD HLTHCARE | 2021-06-07 | 1 |
| ANDA 217848 | GLAND | 2023-07-31 | 3 |
Official labeling on DailyMed
- ARGATROBAN INJECTION [PAR HEALTH USA, LLC] · version 13 · 2026-08-21
- ARGATROBAN INJECTION [PAR HEALTH USA, LLC] · version 11 · 2026-08-20
- ARGATROBAN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 3 · 2026-08-03
- ARGATROBAN INJECTION [MULLAN PHARMACEUTICAL INC.] · version 1 · 2026-06-18
- ARGATROBAN INJECTION [MULLAN PHARMACEUTICAL INC.] · version 2 · 2026-06-18
- ARGATROBAN INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 4 · 2026-06-10
- ARGATROBAN INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 29 · 2026-06-05
- ARGATROBAN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 6 · 2026-05-25
- ARGATROBAN INJECTION [ACCORD HEALTHCARE INC.] · version 8 · 2026-05-25
- ARGATROBAN INJECTION [CAPLIN STERILES LIMITED] · version 5 · 2026-04-20
- ARGATROBAN SOLUTION [GLAND PHARMA LIMITED] · version 5 · 2026-03-18
- ARGATROBAN INJECTION [FRESENIUS KABI USA, LLC] · version 3 · 2025-09-12
Showing the 12 most recent of 16 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.