FDA — authorised 16 July 1957
- Marketing authorisation holder: AUXILIUM PHARMS LLC
- Status: approved
🇺🇸 Robaxin in United States
FDA authorised Robaxin on 16 July 1957
Marketing authorisations
FDA — authorised 22 October 1974
- Application: ANDA084231
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 1975
- Application: ANDA084488
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1975
- Application: ANDA084616
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1975
- Application: ANDA084615
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 1976
- Application: ANDA085159
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 1976
- Application: ANDA085123
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 1976
- Application: ANDA085192
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1976
- Application: ANDA085180
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 1976
- Application: ANDA084756
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 1977
- Application: ANDA084276
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 1977
- Application: ANDA084648
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 1977
- Application: ANDA084649
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 March 1977
- Application: ANDA084277
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 1977
- Application: ANDA085454
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: DELAXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1977
- Application: ANDA085961
- Marketing authorisation holder: CLONMEL HLTHCARE
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1977
- Application: ANDA085963
- Marketing authorisation holder: CLONMEL HLTHCARE
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 February 1980
- Application: ANDA085658
- Marketing authorisation holder: KV PHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 1980
- Application: ANDA085660
- Marketing authorisation holder: KV PHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 1980
- Application: NDA011790
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 3 July 1980
- Application: ANDA086459
- Marketing authorisation holder: DR REDDYS
- Local brand name: METHOCARBAMOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 February 1982
- Application: ANDA084323
- Marketing authorisation holder: MYLAN
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 1982
- Application: ANDA087282
- Marketing authorisation holder: SANDOZ
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 1982
- Application: ANDA087283
- Marketing authorisation holder: SANDOZ
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 1984
- Application: ANDA087660
- Marketing authorisation holder: ASCOT
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 1984
- Application: ANDA087661
- Marketing authorisation holder: ASCOT
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 1991
- Application: ANDA089849
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: METHOCARBAMOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 2003
- Application: ANDA040413
- Marketing authorisation holder: ABLE
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2005
- Application: ANDA040489
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 6 November 2009
- Application: ANDA090200
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2011
- Application: ANDA200958
- Marketing authorisation holder: BOSTAL
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2014
- Application: ANDA204404
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 27 May 2016
- Application: ANDA206128
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 27 October 2016
- Application: ANDA205354
- Marketing authorisation holder: MONTEREY PHARMS LLC
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 19 January 2017
- Application: ANDA208116
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 8 February 2017
- Application: ANDA203550
- Marketing authorisation holder: DBL PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 2017
- Application: ANDA207496
- Marketing authorisation holder: AM REGENT
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 18 July 2017
- Application: ANDA205404
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA207522
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 24 November 2017
- Application: ANDA206071
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA209331
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 7 May 2018
- Application: ANDA209312
- Marketing authorisation holder: GRANULES
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211504
- Marketing authorisation holder: GLAND
- Local brand name: METHOCARBAMOL
- Indication: SOLUTION — IM-IV
- Status: approved
FDA — authorised 12 August 2020
- Application: ANDA213967
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2021
- Application: ANDA212623
- Marketing authorisation holder: POINTVIEW HLDINGS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2023
- Application: ANDA212707
- Marketing authorisation holder: MIKART
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085033
- Marketing authorisation holder: NYLOS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089417
- Marketing authorisation holder: AM THERAP
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089418
- Marketing authorisation holder: AM THERAP
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088731
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089082
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083605
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084846
- Marketing authorisation holder: TABLICAPS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084675
- Marketing authorisation holder: HEATHER
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088646
- Marketing authorisation holder: ROXANE
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085136
- Marketing authorisation holder: FOREST LABS
- Local brand name: FORBAXIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084259
- Marketing authorisation holder: MYLAN
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087590
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087589
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085718
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085137
- Marketing authorisation holder: INWOOD LABS
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088647
- Marketing authorisation holder: ROXANE
- Local brand name: METHOCARBAMOL
- Indication: TABLET — ORAL
- Status: approved
Robaxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Robaxin approved in United States?
Yes. FDA authorised it on 16 July 1957; FDA authorised it on 22 October 1974; FDA authorised it on 11 July 1975.
Who is the marketing authorisation holder for Robaxin in United States?
AUXILIUM PHARMS LLC holds the US marketing authorisation.