FDA — authorised 27 February 1981
- Application: NDA018163
- Marketing authorisation holder: SPECGX LLC
- Local brand name: RESTORIL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Restoril in United States
FDA authorised Restoril on 27 February 1981
Marketing authorisations
FDA — authorised 10 July 1986
- Application: ANDA071174
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 July 1986
- Application: ANDA071175
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1987
- Application: ANDA071456
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1987
- Application: ANDA071457
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 January 1988
- Application: ANDA071427
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 January 1988
- Application: ANDA071428
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 1988
- Application: ANDA071708
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 1988
- Application: ANDA071709
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 May 1993
- Application: ANDA071446
- Marketing authorisation holder: WATSON LABS
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 May 1993
- Application: ANDA071447
- Marketing authorisation holder: WATSON LABS
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 September 2009
- Application: ANDA078581
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 June 2015
- Application: ANDA201781
- Marketing authorisation holder: PRINSTON INC
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 May 2016
- Application: ANDA203482
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA211542
- Marketing authorisation holder: ALEMBIC
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 2019
- Application: ANDA071620
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Indication: Labeling
- Status: approved
FDA — authorised 24 August 2023
- Application: ANDA217875
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070547
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: TEMAZ
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070384
- Marketing authorisation holder: WATSON LABS
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070383
- Marketing authorisation holder: WATSON LABS
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070489
- Marketing authorisation holder: USL PHARMA
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070490
- Marketing authorisation holder: USL PHARMA
- Local brand name: TEMAZEPAM
- Indication: CAPSULE — ORAL
- Status: approved
Restoril in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Restoril approved in United States?
Yes. FDA authorised it on 27 February 1981; FDA authorised it on 10 July 1986; FDA authorised it on 10 July 1986.
Who is the marketing authorisation holder for Restoril in United States?
SPECGX LLC holds the US marketing authorisation.