FDA — authorised 9 August 2012
- Application: ANDA200166
- Marketing authorisation holder: AZURITY
- Local brand name: EVEKEO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Amphetamine Sulfate in United States
FDA authorised Amphetamine Sulfate on 9 August 2012
Marketing authorisations
FDA — authorised 26 September 2018
- Application: ANDA211139
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2020
- Application: ANDA212901
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 2020
- Application: ANDA213898
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA213980
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA213583
- Marketing authorisation holder: SPECGX LLC
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2021
- Application: ANDA212186
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Amphetamine Sulfate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Amphetamine Sulfate approved in United States?
Yes. FDA authorised it on 9 August 2012; FDA authorised it on 26 September 2018; FDA authorised it on 22 May 2020.
Who is the marketing authorisation holder for Amphetamine Sulfate in United States?
AZURITY holds the US marketing authorisation.