Treats dyskinesia. Sold as Symmetrel, Gocovri, Osmolex Er. Every FDA application for this active ingredient: 6 branded and 37 generic.
As of Nov 15, 2026, FDA lists 43 applications for Amantadine Hydrochloride (sold as Symmetrel, Gocovri, Osmolex Er), first approved Feb 14, 1968, with 4 new uses approved and 0 published complete response letters.
| Gocovri | Part D | $124M | +24% | 5,677 |
| Amantadine | Part D | $22.6M | -3% | 109,429 |
| Osmolex ER | Part D | $0K | -100% | 0 |
| Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer PatientsBreast Cancer, Peripheral Neuropathy Due to Chemotherapy · Al-Azhar University | Phase 2 | Not yet recruiting | Oct 22, 2026 |
| Memantine Targeting Neurovascular Dysfunction After Mild and Moderate Traumatic Brain Injury (MEND)Traumatic Brain Injury, Mild Traumatic Brain Injury · Nova Scotia Health Authority | Phase 2 | Not yet recruiting | Oct 9, 2026 |
| Synaptic Mechanisms of Continuous Theta Burst Stimulation in DepressionMajor Depression · Mclean Hospital | Early phase 1 | Recruiting | May 1, 2026 |
| Escalating Doses of Memantine in Down Syndrome (MEDS-123)Down Syndrome, Intellectual Disability · University Hospitals Cleveland Medical Center | Phase 1 | Not yet recruiting | Apr 15, 2026 |
| Neuroprotection of Memantine and RosuvastatinPeripheral Nerve Disease · Tanta University | Phase 2 / Phase 3 | Not yet recruiting | Mar 31, 2026 |
| Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the BrainBrain Tumor · The University of Texas Health Science Center at San Antonio | Phase 2 | Recruiting | Mar 13, 2026 |
| Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain SyndromeAmantadine, Duloxetine · Cairo University | Not applicable | Recruiting | Feb 19, 2026 |
| Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type DementiaAlzheimer Type Dementia · Bigespas LTD | Phase 3 | Recruiting | Nov 26, 2025 |
| Feb 14, 1968 | SymmetrelNDA 16023 · New dosage form | Endo Pharms | 20 | Discontinued |
| Jul 20, 1976 | SymmetrelNDA 17118 · TYPE 6 | Endo Pharms | 9 | Discontinued |
| Nov 3, 1980 | SymmetrelNDA 18101 · New dosage form | Endo Pharms | 9 | Discontinued |
| Jan 7, 1987 | Amantadine HydrochlorideANDA 70589 | Upsher Smith Labs | 29 | Marketed |
| Feb 18, 1987 | Amantadine HydrochlorideANDA 71293 | Sandoz | 26 | Marketed |
| Oct 30, 1990 | Amantadine HydrochlorideANDA 72655 | G And W Labs Inc | 10 | Discontinued |
| Aug 23, 1991 | Amantadine HydrochlorideANDA 73115 | Teva Pharms | 7 | Discontinued |
| Jun 28, 1993 | Amantadine HydrochlorideANDA 74028 | Chartwell Rx | 12 | Marketed |
| Oct 28, 1994 | Amantadine HydrochlorideANDA 74170 | Aurobindo Pharma USA | 4 | Marketed |
| Jul 17, 1995 | Amantadine HydrochlorideANDA 74509 | Pharm Assoc | 12 | Marketed |
| Dec 24, 1998 | Amantadine HydrochlorideANDA 75060 | Pharmobedient | 6 | Marketed |
| Sep 11, 2002 | Amantadine HydrochlorideANDA 75819 | Pharmobedient | 3 | Discontinued |
| Dec 16, 2002 | Amantadine HydrochlorideANDA 76186 | Upsher Smith Labs | 6 | Marketed |
| Sep 10, 2004 | Amantadine HydrochlorideANDA 76352 | Chartwell Rx | 2 | Discontinued |
| Feb 23, 2006 | Amantadine HydrochlorideANDA 77659 | Actavis Elizabeth | 2 | Discontinued |
| Dec 12, 2006 | Amantadine HydrochlorideANDA 77992 | Ph Health | 4 | Discontinued |
| May 29, 2008 | Amantadine HydrochlorideANDA 78720 | Bionpharma | 4 | Marketed |
| May 31, 2016 | Amantadine HydrochlorideANDA 208278 | Zydus Pharms | 2 | Marketed |
| Sep 30, 2016 | Amantadine HydrochlorideANDA 207570 | Invagen Pharms | 1 | Discontinued |
| Dec 6, 2016 | Amantadine HydrochlorideANDA 208107 | Watson Labs Inc | 2 | Discontinued |
| Dec 15, 2016 | Amantadine HydrochlorideANDA 208096 | Watson Labs Inc | 1 | Discontinued |
| Jan 31, 2017 | Amantadine HydrochlorideANDA 207571 | Invagen Pharms | 1 | Discontinued |
| Jun 7, 2017 | Amantadine HydrochlorideANDA 209047 | Strides Pharma | 1 | Marketed |
| Jun 9, 2017 | Amantadine HydrochlorideANDA 209035 | Strides Pharma | 1 | Marketed |
| Jun 12, 2017 | Amantadine HydrochlorideANDA 209171 | Heritage Pharma | 1 | Marketed |
| Jun 15, 2017 | Amantadine HydrochlorideANDA 209221 | Chartwell Molecular | 1 | Discontinued |
| Jun 21, 2017 | Amantadine HydrochlorideANDA 208966 | Alembic | 1 | Marketed |
| Aug 24, 2017 | GocovriNDA 208944 · New dosage form | Supernus Pharms | 3 | Marketed |
| Feb 7, 2018 | Amantadine HydrochlorideANDA 210403 | Jubilant Generics | 2 | Discontinued |
| Feb 16, 2018 | Osmolex ErNDA 209410 · New dosage form | Supernus Pharms | 1 | Discontinued |
| Mar 2, 2020 | Amantadine HydrochlorideANDA 210129 | Rising | 1 | Marketed |
| Mar 10, 2020 | Amantadine HydrochlorideANDA 210215 | Pharmobedient | 1 | Marketed |
| May 21, 2020 | Amantadine HydrochlorideANDA 212044 | Rubicon Research | 1 | Marketed |
| Oct 15, 2020 | Amantadine HydrochlorideANDA 214284 | Alembic | 1 | Marketed |
| Aug 20, 2021 | Amantadine HydrochlorideANDA 214178 | Pharmobedient | 1 | Marketed |
| Feb 18, 2022 | Amantadine HydrochlorideANDA 211354 | Onesource | 1 | Marketed |
| May 27, 2022 | Amantadine HydrochlorideANDA 212407 | Adaptis | 1 | Discontinued |
| Dec 20, 2022 | Amantadine HydrochlorideANDA 214580 | Humanwell Puracap | 1 | Marketed |
| Aug 26, 2024 | Amantadine Hydrochloride, AmantadineANDA 214897 | Zydus | 1 | Discontinued |
| Sep 26, 2024 | Amantadine HydrochlorideANDA 218598 | Zhejiang Jutai Pharm | 1 | Marketed |
| — | SymmetrelNDA 16020 | Endo Pharms | 0 | Discontinued |
| — | SymadineANDA 71000 | Solvay | 0 | Discontinued |
| — | Amantadine HydrochlorideANDA 71382 | Watson Labs | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sandoz
Aurobindo Pharma USA
Zydus Pharms
Strides Pharma
Alembic