FDA — authorised 22 May 2007
- Application: NDA021303
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
🇺🇸 Amphetamine Sulfate in United States
FDA authorised Amphetamine Sulfate on 22 May 2007
Marketing authorisations
FDA — authorised 9 August 2012
- Application: ANDA200166
- Marketing authorisation holder: AZURITY
- Local brand name: EVEKEO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2015
- Application: ANDA040440
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
FDA — authorised 28 December 2017
- Application: ANDA209799
- Marketing authorisation holder: NUVO PHARM
- Status: approved
FDA — authorised 26 September 2018
- Application: ANDA211139
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2019
- Application: NDA209905
- Marketing authorisation holder: AZURITY
- Local brand name: EVEKEO ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 5 August 2019
- Application: ANDA212619
- Marketing authorisation holder: GRANULES
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2019
- Application: ANDA212919
- Marketing authorisation holder: BIONPHARMA
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 2020
- Application: ANDA212582
- Marketing authorisation holder: SANALUZ
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2020
- Application: ANDA211861
- Marketing authorisation holder: PRINSTON INC
- 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 24 August 2020
- Application: ANDA213763
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA213720
- Marketing authorisation holder: ALKEM LABS LTD
- 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 — authorised 27 January 2021
- Application: ANDA214574
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: AMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2023
- Application: ANDA040444
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 14 June 2024
- Application: ANDA040439
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
The FDA approved Amphetamine Sulfate for labeling indications, marking the marketing authorization granted to Sandoz on June 14, 2024. This approval was made through a standard expedited pathway. The application number for this approval is ANDA040439.
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 22 May 2007; FDA authorised it on 9 August 2012; FDA authorised it on 17 April 2015.
Who is the marketing authorisation holder for Amphetamine Sulfate in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.