FDA — authorised 30 December 1992
- Application: NDA019941
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: EMLA
- Indication: CREAM — TOPICAL
- Status: approved
FDA authorised Eutectic Lidocaine Prilocaine on 30 December 1992
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 December 1992; FDA has authorised it.
TEVA BRANDED PHARM holds the US marketing authorisation.