FDA — authorised 28 February 1997
- Application: ANDA074673
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SPD503 in United States
FDA authorised SPD503 on 28 February 1997
Marketing authorisations
FDA — authorised 25 June 1997
- Application: ANDA074762
- Marketing authorisation holder: WATSON LABS
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2012
- Application: ANDA200881
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 June 2015
- Application: ANDA202578
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 June 2015
- Application: ANDA202568
- Marketing authorisation holder: SANDOZ
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 October 2015
- Application: ANDA202238
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA205689
- Marketing authorisation holder: SUN PHARM
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 March 2021
- Application: ANDA214689
- Marketing authorisation holder: UNICHEM
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2023
- Application: ANDA217293
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 2023
- Application: ANDA216762
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2024
- Application: ANDA218326
- Marketing authorisation holder: XIROMED
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2024
- Application: ANDA217638
- Marketing authorisation holder: FOSUN WANBANG
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 November 2024
- Application: ANDA219033
- Marketing authorisation holder: UNICHEM
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA219689
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 March 2026
- Application: ANDA220675
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: GUANFACINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is SPD503 approved in United States?
Yes. FDA authorised it on 28 February 1997; FDA authorised it on 25 June 1997; FDA authorised it on 5 October 2012.
Who is the marketing authorisation holder for SPD503 in United States?
EPIC PHARMA LLC holds the US marketing authorisation.