FDA — authorised 30 January 2015
- Application: ANDA079225
- Marketing authorisation holder: RISING
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 MEMANTINE HYDROCHLORIDE in United States
FDA authorised MEMANTINE HYDROCHLORIDE on 30 January 2015 · 1,380 US adverse-event reports
Marketing authorisations
FDA — authorised 13 October 2015
- Application: ANDA200891
- Marketing authorisation holder: ALEMBIC
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA202840
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA203175
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA091585
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA200155
- Marketing authorisation holder: TORRENT
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA200022
- Marketing authorisation holder: UNICHEM
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2015
- Application: ANDA204033
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 November 2015
- Application: ANDA206855
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2015
- Application: ANDA206528
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA206032
- Marketing authorisation holder: RISING
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA206028
- Marketing authorisation holder: LUPIN
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA205905
- Marketing authorisation holder: SUN PHARM
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 October 2016
- Application: ANDA205825
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 10 November 2016
- Application: ANDA207236
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2016
- Application: ANDA206135
- Marketing authorisation holder: APOTEX
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 May 2017
- Application: ANDA202350
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2017
- Application: ANDA205784
- Marketing authorisation holder: PH HEALTH
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 July 2017
- Application: ANDA090961
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2017
- Application: ANDA203293
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 February 2018
- Application: ANDA209955
- Marketing authorisation holder: APOTEX
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 May 2018
- Application: ANDA209527
- Marketing authorisation holder: RENATA
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2018
- Application: ANDA090244
- Marketing authorisation holder: CHARTWELL
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2020
- Application: ANDA205365
- Marketing authorisation holder: ANI PHARMS
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2020
- Application: ANDA208173
- Marketing authorisation holder: HIKMA
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2020
- Application: ANDA212947
- Marketing authorisation holder: YILING
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the marketing authorisation for MEMANTINE HYDROCHLORIDE to YILING on 17 May 2024. This approval was granted under the standard expedited pathway for manufacturing (CMC) purposes. The application number for this approval is ANDA212947.
FDA — authorised 31 August 2020
- Application: ANDA210319
- Marketing authorisation holder: MEDLEY PHARMS
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 December 2020
- Application: ANDA210587
- Marketing authorisation holder: PURACAP LABS BLU
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2021
- Application: ANDA211100
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 August 2021
- Application: ANDA214651
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 26 September 2022
- Application: ANDA204389
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 2022
- Application: ANDA213985
- Marketing authorisation holder: VITRUVIAS
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 August 2025
- Application: ANDA206310
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA214731
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: MEMANTINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — 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: 1,380
Most-reported reactions
- Fall — 221 reports (16.01%)
- Asthenia — 158 reports (11.45%)
- Fatigue — 152 reports (11.01%)
- Confusional State — 136 reports (9.86%)
- Drug Ineffective — 130 reports (9.42%)
- Somnolence — 123 reports (8.91%)
- Condition Aggravated — 122 reports (8.84%)
- Nausea — 118 reports (8.55%)
- Off Label Use — 114 reports (8.26%)
- Pneumonia — 106 reports (7.68%)
MEMANTINE HYDROCHLORIDE 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 MEMANTINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 January 2015; FDA authorised it on 13 October 2015; FDA authorised it on 13 October 2015.
Who is the marketing authorisation holder for MEMANTINE HYDROCHLORIDE in United States?
RISING holds the US marketing authorisation.