FDA — authorised 3 January 2019
- Application: ANDA208002
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LURASIDONE HYDROCHLORIDE in United States
FDA authorised LURASIDONE HYDROCHLORIDE on 3 January 2019
Marketing authorisations
FDA — authorised 3 January 2019
- Application: ANDA208055
- Marketing authorisation holder: TORRENT
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2019
- Application: ANDA208049
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2019
- Application: ANDA208031
- Marketing authorisation holder: LUPIN
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2019
- Application: ANDA208028
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2019
- Application: ANDA208066
- Marketing authorisation holder: SUN PHARM
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 2019
- Application: ANDA208052
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2019
- Application: ANDA208060
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2019
- Application: ANDA208058
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2020
- Application: ANDA212091
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2021
- Application: ANDA208016
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2021
- Application: ANDA213248
- Marketing authorisation holder: ALEMBIC
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2021
- Application: ANDA208047
- Marketing authorisation holder: DR REDDYS
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 2022
- Application: ANDA208037
- Marketing authorisation holder: MSN
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2022
- Application: ANDA212244
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2023
- Application: ANDA208045
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2023
- Application: ANDA212124
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2024
- Application: ANDA218174
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 2024
- Application: ANDA210388
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA207948
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: LURASIDONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
LURASIDONE 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 LURASIDONE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 3 January 2019; FDA authorised it on 3 January 2019; FDA authorised it on 3 January 2019.
Who is the marketing authorisation holder for LURASIDONE HYDROCHLORIDE in United States?
AMNEAL PHARMS CO holds the US marketing authorisation.