FDA — authorised 22 July 2005
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: approved
🇺🇸 Rozerem in United States
FDA authorised Rozerem on 22 July 2005
Marketing authorisations
FDA — authorised 22 July 2005
- Application: NDA021782
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ROZEREM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 2015
- Application: ANDA091610
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2019
- Application: ANDA211567
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2020
- Application: ANDA213186
- Marketing authorisation holder: GRANULES
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2022
- Application: ANDA215435
- Marketing authorisation holder: ANDAS 5 HOLDING
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2022
- Application: ANDA216209
- Marketing authorisation holder: XIROMED
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2023
- Application: ANDA215243
- Marketing authorisation holder: MICRO LABS
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 2023
- Application: ANDA215972
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: RAMELTEON
- Indication: TABLET — ORAL
- Status: approved
Rozerem 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 Rozerem approved in United States?
Yes. FDA authorised it on 22 July 2005; FDA authorised it on 22 July 2005; FDA authorised it on 19 August 2015.
Who is the marketing authorisation holder for Rozerem in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.