FDA — authorised 29 May 1975
- Application: ANDA084051
- Marketing authorisation holder: SHIRE
- Local brand name: DEXTROSTAT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DEXTROAMPHETAMINE SULFATE in United States
FDA authorised DEXTROAMPHETAMINE SULFATE on 29 May 1975 · 1,110 US adverse-event reports
Marketing authorisations
FDA — authorised 2 August 1976
- Application: NDA017078
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: DEXEDRINE SPANSULE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 June 1977
- Application: ANDA084001
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: FERNDEX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 June 1980
- Application: ANDA085652
- Marketing authorisation holder: LANNETT
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 1999
- Application: ANDA040299
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2001
- Application: ANDA040361
- Marketing authorisation holder: BARR
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2002
- Application: ANDA076137
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 January 2002
- Application: ANDA040436
- Marketing authorisation holder: SPECGX LLC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2002
- Application: ANDA040367
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2002
- Application: ANDA040365
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 2003
- Application: ANDA076353
- Marketing authorisation holder: SPECGX LLC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 August 2004
- Application: ANDA076814
- Marketing authorisation holder: ABLE
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 October 2011
- Application: ANDA090533
- Marketing authorisation holder: AZURITY
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2013
- Application: ANDA203644
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 July 2013
- Application: ANDA202893
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2014
- Application: ANDA090652
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2015
- Application: ANDA203548
- Marketing authorisation holder: AVANTHI INC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA206735
- Marketing authorisation holder: QUAGEN
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 March 2016
- Application: ANDA204330
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2016
- Application: ANDA206588
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2017
- Application: ANDA209111
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 2017
- Application: ANDA210059
- Marketing authorisation holder: NUVO PHARM
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2017
- Application: ANDA205673
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 January 2019
- Application: ANDA205401
- Marketing authorisation holder: ANI PHARMS
- Status: supplemented
FDA — authorised 21 June 2019
- Application: ANDA205077
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 April 2021
- Application: ANDA213709
- Marketing authorisation holder: ASCENT PHARMS INC
- Status: supplemented
FDA — authorised 7 June 2021
- Application: ANDA212160
- Marketing authorisation holder: WINDER LABS LLC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2022
- Application: ANDA210876
- Marketing authorisation holder: TEVA PHARMS USA
- Status: supplemented
FDA — authorised 18 August 2022
- Application: ANDA206095
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA086521
- Marketing authorisation holder: MAST MM
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085892
- Marketing authorisation holder: VITARINE
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085355
- Marketing authorisation holder: TEVA
- Local brand name: DEXAMPEX
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083735
- Marketing authorisation holder: TEVA
- Local brand name: DEXAMPEX
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084125
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DEXTROAMPHETAMINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,110
Most-reported reactions
- Drug Ineffective — 334 reports (30.09%)
- Fatigue — 118 reports (10.63%)
- Nausea — 101 reports (9.1%)
- Headache — 97 reports (8.74%)
- Anxiety — 95 reports (8.56%)
- Product Substitution Issue — 89 reports (8.02%)
- Somnolence — 79 reports (7.12%)
- Feeling Abnormal — 70 reports (6.31%)
- Disturbance In Attention — 69 reports (6.22%)
- Dizziness — 58 reports (5.23%)
DEXTROAMPHETAMINE SULFATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DEXTROAMPHETAMINE SULFATE approved in United States?
Yes. FDA authorised it on 29 May 1975; FDA authorised it on 2 August 1976; FDA authorised it on 15 June 1977.
Who is the marketing authorisation holder for DEXTROAMPHETAMINE SULFATE in United States?
SHIRE holds the US marketing authorisation.