approval · primary record
ARGATROBAN
8 approval events · latest 2026-09-25
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-09-25 |
| Approval events | 8 |
| Brand | ARGATROBAN IN SODIUM CHLORIDE |
| Sponsor | PLANO PHARMS |
| Route | INTRAVENOUS |
Approval history
8 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-09-25 | FDA | NDA | ARGATROBAN IN SODIUM CHLORIDE | PLANO PHARMS | INTRAVENOUS |
| 2026-07-31 | FDA | NDA | ARGATROBAN IN SODIUM CHLORIDE | ACCORD HLTHCARE | INTRAVENOUS |
| 2026-07-13 | FDA | NDA | ARGATROBAN | FRESENIUS KABI USA | INJECTION |
| 2026-06-26 | FDA | NDA | ARGATROBAN IN 0.9% SODIUM CHLORIDE | TEVA PHARMS USA | INTRAVENOUS |
| 2026-06-16 | FDA | NDA | ARGATROBAN | SANDOZ | INJECTION |
| 2026-06-10 | FDA | NDA | ARGATROBAN IN SODIUM CHLORIDE | EUGIA PHARMA SPECLTS | INTRAVENOUS |
| 2026-06-03 | FDA | NDA | ARGATROBAN IN DEXTROSE | SANDOZ | INTRAVENOUS |
| 2026-05-15 | FDA | NDA | ARGATROBAN | HIKMA PHARM CO LTD | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:29:12.354Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:argatroban
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Argatroban · compound