FDA — authorised 6 May 2003
- Application: ANDA076353
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
🇺🇸 DEXTROAMPHETAMINE in United States
FDA authorised DEXTROAMPHETAMINE on 6 May 2003 · 7,603 US adverse-event reports
Marketing authorisations
FDA — authorised 22 May 2007
- Application: NDA021303
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 17 April 2015
- Application: ANDA040436
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
FDA — authorised 17 April 2015
- Application: ANDA040776
- Marketing authorisation holder: PRASCO
- Indication: Labeling
- Status: approved
FDA — authorised 28 December 2017
- Application: ANDA209799
- Marketing authorisation holder: NUVO PHARM
- Status: approved
FDA — authorised 22 January 2019
- Application: ANDA205401
- Marketing authorisation holder: ANI PHARMS
- Status: supplemented
FDA — authorised 22 April 2021
- Application: ANDA213709
- Marketing authorisation holder: ASCENT PHARMS INC
- Status: supplemented
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
- 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: 7,603
Most-reported reactions
- Drug Ineffective — 2,153 reports (28.32%)
- Fatigue — 817 reports (10.75%)
- Product Substitution Issue — 738 reports (9.71%)
- Headache — 731 reports (9.61%)
- Nausea — 644 reports (8.47%)
- Anxiety — 633 reports (8.33%)
- Somnolence — 498 reports (6.55%)
- Feeling Abnormal — 493 reports (6.48%)
- Depression — 482 reports (6.34%)
- Disturbance In Attention — 414 reports (5.45%)
DEXTROAMPHETAMINE 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 DEXTROAMPHETAMINE approved in United States?
Yes. FDA authorised it on 6 May 2003; FDA authorised it on 22 May 2007; FDA authorised it on 17 April 2015.
Who is the marketing authorisation holder for DEXTROAMPHETAMINE in United States?
SPECGX LLC holds the US marketing authorisation.