FDA — authorised 4 September 1985
- Application: ANDA070325
- Marketing authorisation holder: MYLAN
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Valium in United States
FDA authorised Valium on 4 September 1985
Marketing authorisations
FDA — authorised 16 December 1985
- Application: ANDA070312
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 December 1985
- Application: ANDA070311
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 December 1985
- Application: ANDA070313
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1985
- Application: ANDA070302
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1985
- Application: ANDA070304
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1985
- Application: ANDA070303
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA070296
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 February 1986
- Application: ANDA070462
- Marketing authorisation holder: VIRTUS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1986
- Application: ANDA070464
- Marketing authorisation holder: NUVO PHARM
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1986
- Application: ANDA070463
- Marketing authorisation holder: VIRTUS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 1986
- Application: ANDA070707
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 1986
- Application: ANDA070706
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1986
- Application: ANDA070956
- Marketing authorisation holder: HALSEY
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA071322
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1986
- Application: ANDA071321
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 1987
- Application: ANDA071415
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM INTENSOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 16 April 1987
- Application: ANDA070424
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: Q-PAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1987
- Application: ANDA070425
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: Q-PAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1987
- Application: ANDA071310
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 1987
- Application: ANDA071309
- Marketing authorisation holder: HIKMA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 April 1988
- Application: ANDA070662
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1988
- Application: ANDA072079
- Marketing authorisation holder: HOSPIRA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 1988
- Application: ANDA070928
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 January 1990
- Application: ANDA070358
- Marketing authorisation holder: ROXANE
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1990
- Application: ANDA070356
- Marketing authorisation holder: ROXANE
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1990
- Application: ANDA070357
- Marketing authorisation holder: ROXANE
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 1990
- Application: NDA020124
- Marketing authorisation holder: US ARMY
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 1997
- Application: NDA020648
- Marketing authorisation holder: BAUSCH
- Local brand name: DIASTAT
- Indication: GEL — RECTAL
- Status: approved
FDA — authorised 30 August 2000
- Application: NDA013263
- Marketing authorisation holder: WAYLIS THERAP
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 April 2004
- Application: ANDA076815
- Marketing authorisation holder: PARENTA PHARMS
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2006
- Application: ANDA077749
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 2014
- Application: ANDA204433
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: DIAZEPAM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 6 April 2015
- Application: ANDA071583
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 24 June 2016
- Application: ANDA206477
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: DIAZEPAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 March 2019
- Application: ANDA210363
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 2019
- Application: ANDA211998
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 November 2022
- Application: ANDA214745
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 December 2023
- Application: ANDA217843
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA218450
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 18 July 2024
- Application: ANDA218422
- Marketing authorisation holder: DR REDDYS
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 May 2025
- Application: ANDA216422
- Marketing authorisation holder: GALENICUM HLTH
- Local brand name: DIAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA217468
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: DIAZEPAM
- Indication: GEL — RECTAL
- Status: approved
FDA
- Application: ANDA219320
- Marketing authorisation holder: PADAGIS ISRAEL PHARMA LTD
- Local brand name: DIAZEPAM
- Indication: Spray
- Status: approved
FDA
- Application: ANDA070360
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA018179
- Marketing authorisation holder: ROCHE
- Local brand name: VALRELEASE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA019287
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: DIZAC
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070456
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070457
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070458
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070996
- Marketing authorisation holder: HALSEY
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070987
- Marketing authorisation holder: HALSEY
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070361
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070423
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: Q-PAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070362
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DIAZEPAM
- Indication: TABLET — ORAL
- Status: approved
Valium 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 Valium approved in United States?
Yes. FDA authorised it on 4 September 1985; FDA authorised it on 16 December 1985; FDA authorised it on 16 December 1985.
Who is the marketing authorisation holder for Valium in United States?
MYLAN holds the US marketing authorisation.