approval · primary record
LIDOCAINE HYDROCHLORIDE
3 approval events · latest 2026-08-17
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-08-17 |
| Approval events | 3 |
| Brand | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
| Sponsor | FRESENIUS KABI USA |
| Route | INJECTION |
Approval history
3 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 |
|---|---|---|---|---|---|
| 2026-08-17 | FDA | NDA | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | FRESENIUS KABI USA | INJECTION |
| 2025-11-21 | FDA | NDA | AKTEN | THEA PHARMA | OPHTHALMIC |
| 2025-04-01 | FDA | NDA | XYLOCAINE | EPIC PHARMA LLC | TOPICAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:32:12.927Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:lidocaine-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Lidocaine Hydrochloride · compound