FDA — authorised 15 April 1999
- Application: NDA021039
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: AGENERASE
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Agenerase in United States
FDA authorised Agenerase on 15 April 1999
Marketing authorisations
FDA — authorised 15 April 1999
- Application: NDA021007
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: AGENERASE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Agenerase in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Agenerase approved in United States?
Yes. FDA authorised it on 15 April 1999; FDA authorised it on 15 April 1999; FDA has authorised it.
Who is the marketing authorisation holder for Agenerase in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.