approval · primary record
EPINEPHRINE
11 approval events · latest 2026-10-19
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-10-19 |
| Approval events | 11 |
| Brand | ADRENALIN |
| Sponsor | PH HEALTH |
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
Approval history
11 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 |
|---|---|---|---|---|---|
| 2026-10-19 | FDA | NDA | ADRENALIN | PH HEALTH | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 2026-06-22 | FDA | NDA | ADRENALIN | PH HEALTH | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 2026-03-30 | FDA | NDA | EPINEPHRINE | BAXTER HLTHCARE CORP | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 2026-03-26 | FDA | NDA | NEFFY | ARS PHARMS OPERATION | NASAL |
| 2026-03-20 | FDA | NDA | EPIPEN E Z PEN | VIATRIS | INTRAMUSCULAR |
| 2026-03-19 | FDA | NDA | ADRENACLICK | IMPAX | INTRAMUSCULAR, SUBCUTANEOUS |
| 2025-06-30 | FDA | NDA | EPINEPHRINE | BPI LABS | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 2025-05-13 | FDA | NDA | EPINEPHRINE | HOSPIRA | INTRAVENOUS |
| 2025-04-30 | FDA | NDA | AUVI-Q | KALEO INC | INTRAMUSCULAR, SUBCUTANEOUS |
| 2025-03-13 | FDA | NDA | EPINEPHRINE | FRESENIUS KABI USA | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 2024-10-30 | FDA | NDA | XYLOCAINE W/ EPINEPHRINE | FRESENIUS KABI USA | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:27:54.361Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:epinephrine
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Epinephrine · compound