FDA — authorised 14 February 1968
- Application: NDA016023
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: SYMMETREL
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 Amantadine Hydrochloride, USP in United States
FDA authorised Amantadine Hydrochloride, USP on 14 February 1968
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA016020
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: SYMMETREL
- Indication: CAPSULE — ORAL
- Status: approved
Amantadine Hydrochloride, USP in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Amantadine Hydrochloride, USP approved in United States?
Yes. FDA authorised it on 14 February 1968; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Amantadine Hydrochloride, USP in United States?
ENDO PHARMS holds the US marketing authorisation.