FDA — authorised 9 April 1959
- Application: NDA011792
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: SOMA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Soma in United States
FDA authorised Soma on 9 April 1959
Marketing authorisations
FDA — authorised 12 June 1979
- Application: ANDA086179
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 1982
- Application: ANDA087499
- Marketing authorisation holder: WATSON LABS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1989
- Application: ANDA081025
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1991
- Application: ANDA089346
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 1996
- Application: ANDA040124
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1996
- Application: ANDA040118
- Marketing authorisation holder: SANDOZ
- Local brand name: CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 1996
- Application: ANDA040152
- Marketing authorisation holder: WATSON LABS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 1997
- Application: ANDA040245
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1998
- Application: ANDA040283
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1999
- Application: ANDA040188
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 September 2000
- Application: ANDA040397
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2001
- Application: ANDA040421
- Marketing authorisation holder: ABLE
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 June 2005
- Application: ANDA040576
- Marketing authorisation holder: ACCELRX LABS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2007
- Application: ANDA040755
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2008
- Application: ANDA040823
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2010
- Application: ANDA040860
- Marketing authorisation holder: INGENUS PHARMS NJ
- Local brand name: CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2010
- Application: ANDA040792
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 27 January 2014
- Application: ANDA203374
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2014
- Application: ANDA205085
- Marketing authorisation holder: ORIENT PHARMA CO LTD
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2014
- Application: ANDA090988
- Marketing authorisation holder: NATCO
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 2015
- Application: ANDA205126
- Marketing authorisation holder: HERITAGE
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2015
- Application: ANDA205513
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2017
- Application: ANDA207237
- Marketing authorisation holder: MPP PHARMA
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2021
- Application: ANDA211789
- Marketing authorisation holder: POINTVIEW HLDINGS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089566
- Marketing authorisation holder: SANDOZ
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089390
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: CARISOPRODOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA012155
- Marketing authorisation holder: SCHERING
- Local brand name: RELA
- Indication: TABLET — ORAL
- Status: approved
Soma 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 Soma approved in United States?
Yes. FDA authorised it on 9 April 1959; FDA authorised it on 12 June 1979; FDA authorised it on 20 April 1982.
Who is the marketing authorisation holder for Soma in United States?
MYLAN SPECIALITY LP holds the US marketing authorisation.