FDA — authorised 10 December 1985
- Application: ANDA070472
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LORAZEPAM in United States
FDA authorised LORAZEPAM on 10 December 1985 · 72,343 US adverse-event reports
Marketing authorisations
FDA — authorised 10 December 1985
- Application: ANDA070473
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1985
- Application: ANDA070474
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 1986
- Application: ANDA071110
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 1986
- Application: ANDA071118
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 1986
- Application: ANDA071117
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1987
- Application: ANDA071086
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1987
- Application: ANDA071087
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1987
- Application: ANDA071088
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 1987
- Application: ANDA071141
- Marketing authorisation holder: SANDOZ
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 1987
- Application: ANDA071404
- Marketing authorisation holder: SANDOZ
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 1988
- Application: ANDA071038
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 1988
- Application: ANDA071039
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1988
- Application: ANDA071194
- Marketing authorisation holder: SANDOZ
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1988
- Application: ANDA071193
- Marketing authorisation holder: SANDOZ
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1988
- Application: ANDA071195
- Marketing authorisation holder: SANDOZ
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 1991
- Application: ANDA072555
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1991
- Application: ANDA072755
- Marketing authorisation holder: HIKMA
- Local brand name: LORAZEPAM INTENSOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 31 October 1991
- Application: ANDA072926
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1991
- Application: ANDA072928
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1991
- Application: ANDA072927
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 1994
- Application: ANDA074300
- Marketing authorisation holder: HOSPIRA
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 1994
- Application: ANDA074243
- Marketing authorisation holder: HOSPIRA
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 1994
- Application: ANDA074276
- Marketing authorisation holder: WATSON LABS
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 May 1994
- Application: ANDA074282
- Marketing authorisation holder: HOSPIRA
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 May 1994
- Application: ANDA074280
- Marketing authorisation holder: HOSPIRA
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 September 1996
- Application: ANDA074535
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 September 1996
- Application: ANDA074551
- Marketing authorisation holder: CAPLIN
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 1997
- Application: ANDA074648
- Marketing authorisation holder: ROXANE
- Local brand name: LORAZEPAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 July 1998
- Application: ANDA075025
- Marketing authorisation holder: RISING
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 July 1998
- Application: ANDA074974
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 2001
- Application: ANDA076045
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 November 2004
- Application: ANDA076150
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 2005
- Application: ANDA077076
- Marketing authorisation holder: BEDFORD
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 2005
- Application: ANDA077074
- Marketing authorisation holder: BEDFORD LABS
- Local brand name: LORAZEPAM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 March 2006
- Application: ANDA077657
- Marketing authorisation holder: RISING
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2006
- Application: ANDA077754
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2006
- Application: ANDA077396
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2009
- Application: ANDA079244
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: LORAZEPAM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 15 June 2010
- Application: ANDA090260
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: LORAZEPAM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 23 June 2010
- Application: ANDA078826
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2012
- Application: ANDA200169
- Marketing authorisation holder: HIKMA
- Local brand name: LORAZEPAM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 4 April 2017
- Application: ANDA200217
- Marketing authorisation holder: RISING
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA203572
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2021
- Application: NDA214826
- Marketing authorisation holder: ALMATICA
- Local brand name: LOREEV XR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 November 2024
- Application: ANDA217598
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LORAZEPAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070201
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: LORAZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070200
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: LORAZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070677
- Marketing authorisation holder: PAR PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070675
- Marketing authorisation holder: PAR PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070729
- Marketing authorisation holder: AM THERAP
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070676
- Marketing authorisation holder: PAR PHARM
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071434
- Marketing authorisation holder: HALSEY
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071435
- Marketing authorisation holder: HALSEY
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071436
- Marketing authorisation holder: HALSEY
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070728
- Marketing authorisation holder: AM THERAP
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070727
- Marketing authorisation holder: AM THERAP
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA070540
- Marketing authorisation holder: USL PHARMA
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070539
- Marketing authorisation holder: USL PHARMA
- Local brand name: LORAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070202
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: LORAZ
- Indication: TABLET — 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: 72,343
Most-reported reactions
- Drug Ineffective — 9,402 reports (13%)
- Fatigue — 9,106 reports (12.59%)
- Nausea — 8,972 reports (12.4%)
- Off Label Use — 7,687 reports (10.63%)
- Diarrhoea — 7,274 reports (10.05%)
- Dyspnoea — 6,356 reports (8.79%)
- Vomiting — 6,074 reports (8.4%)
- Headache — 5,925 reports (8.19%)
- Anxiety — 5,785 reports (8%)
- Dizziness — 5,762 reports (7.96%)
LORAZEPAM 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 LORAZEPAM approved in United States?
Yes. FDA authorised it on 10 December 1985; FDA authorised it on 10 December 1985; FDA authorised it on 10 December 1985.
Who is the marketing authorisation holder for LORAZEPAM in United States?
MUTUAL PHARM holds the US marketing authorisation.