Active substance
Amfetamine
- US FDA 22
- US price lines 8
- Safety 17
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| EVEKEO | 5MG; 10MG | tablet · oral | AZURITY | Prescription | 9 Aug 2012 |
| ADZENYS XR-ODT | EQ 3.1MG BASE; EQ 6.3MG BASE; EQ 9.4MG BASE; EQ 12.5MG BASE; EQ 15.7MG BASE; EQ 18.8MG BASE | tablet, orally disintegrating, extended release · oral | NEOS THERAPS | Prescription | 27 Jan 2016 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | AMNEAL PHARMS | Prescription | 26 Sep 2018 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | AUROLIFE PHARMA LLC | Prescription | 17 Apr 2019 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | GRANULES | Prescription | 5 Aug 2019 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | BIONPHARMA | Prescription | 22 Nov 2019 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | SANALUZ | Prescription | 4 Feb 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | PRINSTON INC | Prescription | 11 Mar 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | SENORES PHARMS | Prescription | 22 May 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | ALKEM LABS LTD | Prescription | 27 Oct 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | EPIC PHARMA LLC | Prescription | 27 Oct 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | SPECGX LLC | Prescription | 22 Jan 2021 |
| AMPHETAMINE | EQ 3.1MG BASE; EQ 6.3MG BASE; EQ 9.4MG BASE; EQ 12.5MG BASE; EQ 15.7MG BASE; EQ 18.8MG BASE | tablet, orally disintegrating, extended release · oral | ACTAVIS LABS FL INC | Prescription | 22 Jun 2023 |
| BENZEDRINE | 5MG; 10MG | tablet · oral | SMITH KLINE & FRENCH | Discontinued | 26 Feb 1976 |
| AMPHETAMINE SULFATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LANNETT | Discontinued | 31 Aug 1984 |
| ADZENYS ER | EQ 1.25MG BASE/ML | suspension, extended release · oral | NEOS THERAPS INC | Discontinued | 15 Sep 2017 |
| EVEKEO ODT | 5MG; 10MG; 15MG; 20MG; 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, orally disintegrating · oral | AZURITY | Discontinued | 30 Jan 2019 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | DR REDDYS LABS SA | Discontinued | 14 Jul 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | INGENUS PHARMS LLC | Discontinued | 24 Aug 2020 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | GLENMARK PHARMS LTD | Discontinued | 27 Jan 2021 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 27 Jan 2021 |
| AMPHETAMINE SULFATE | 5MG; 10MG | tablet · oral | RHODES PHARMS | Discontinued | 7 Sep 2021 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AMPHETAMINE ER 12.5 MG ODT | $15.96228 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE ER 15.7 MG ODT | $15.92901 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE ER 18.8 MG ODT | $15.61431 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE ER 3.1 MG ODT | $15.84156 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE ER 6.3 MG ODT | $16.07321 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE ER 9.4 MG ODT | $16.21781 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE SULFATE 10 MG TAB | $0.44899 | per EA | 23 Sep 2026 |
| US NADAC | AMPHETAMINE SULFATE 5 MG TAB | $0.45734 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Apr 2026 ADDERALL XR 10 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Apr 2026 MYDAYIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 ADZENYS XR-ODT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 DYANAVEL XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 DYANAVEL XR 10 — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 DYANAVEL XR 15 — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 DYANAVEL XR 20 — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 DYANAVEL XR 5 — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 10 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 12.5 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 15 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 20 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 30 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 5 — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 ADDERALL 7.5 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.