FDA — authorised 16 October 2003
- Application: NDA021487
- Marketing authorisation holder: ABBVIE
- Local brand name: NAMENDA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Memantine Oral Tablet in United States
FDA authorised Memantine Oral Tablet on 16 October 2003
Marketing authorisations
FDA — authorised 21 June 2010
- Application: NDA022525
- Marketing authorisation holder: ABBVIE
- Local brand name: NAMENDA XR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA076799
- Marketing authorisation holder: ALPHAPHARM
- Local brand name: PIOGLITAZONE
- Indication: TABLET — ORAL
- Status: approved
Memantine Oral Tablet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neurology approved in United States
Frequently asked questions
Is Memantine Oral Tablet approved in United States?
Yes. FDA authorised it on 16 October 2003; FDA authorised it on 21 June 2010; FDA has authorised it.
Who is the marketing authorisation holder for Memantine Oral Tablet in United States?
ABBVIE holds the US marketing authorisation.