FDA — authorised 18 April 2005
- Application: ANDA076489
- Marketing authorisation holder: ROXANE
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 SPD422 in United States
FDA authorised SPD422 on 18 April 2005
Marketing authorisations
FDA — authorised 18 April 2005
- Application: ANDA076468
- Marketing authorisation holder: CIPLA
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 2005
- Application: ANDA076811
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 2005
- Application: ANDA076530
- Marketing authorisation holder: BARR LABS
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 2005
- Application: ANDA076683
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 2005
- Application: ANDA076910
- Marketing authorisation holder: IMPAX LABS
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 2017
- Application: ANDA209151
- Marketing authorisation holder: TORRENT
- Local brand name: ANAGRELIDE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is SPD422 approved in United States?
Yes. FDA authorised it on 18 April 2005; FDA authorised it on 18 April 2005; FDA authorised it on 18 April 2005.
Who is the marketing authorisation holder for SPD422 in United States?
ROXANE holds the US marketing authorisation.