FDA — authorised 21 February 1979
- Application: ANDA086237
- Marketing authorisation holder: WATSON LABS
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Butalbital, Aspirin And Caffeine in United States
FDA authorised Butalbital, Aspirin And Caffeine on 21 February 1979
Marketing authorisations
FDA — authorised 5 June 1979
- Application: ANDA086162
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 1979
- Application: ANDA086710
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1980
- Application: ANDA087048
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 1980
- Application: ANDA086398
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1982
- Application: ANDA086231
- Marketing authorisation holder: WATSON LABS
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 1984
- Application: ANDA088616
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 1985
- Application: ANDA088758
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 1985
- Application: ANDA088765
- Marketing authorisation holder: GRAHAM DM
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 1985
- Application: ANDA089067
- Marketing authorisation holder: GRAHAM DM
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 July 1985
- Application: ANDA088743
- Marketing authorisation holder: GRAHAM DM
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 March 1986
- Application: ANDA089007
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 June 1995
- Application: ANDA089718
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 1995
- Application: ANDA074359
- Marketing authorisation holder: WATSON LABS
- Local brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 1998
- Application: ANDA040267
- Marketing authorisation holder: WATSON LABS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 1998
- Application: ANDA074951
- Marketing authorisation holder: STEVENS J
- Local brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 1998
- Application: ANDA040261
- Marketing authorisation holder: HIKMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 March 1999
- Application: ANDA075351
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 August 1999
- Application: ANDA040336
- Marketing authorisation holder: HIKMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2001
- Application: ANDA075618
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 July 2001
- Application: ANDA040390
- Marketing authorisation holder: ABLE
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2001
- Application: ANDA040394
- Marketing authorisation holder: ABLE
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2001
- Application: ANDA075231
- Marketing authorisation holder: LGM PHARMA
- Local brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 2002
- Application: ANDA075929
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 January 2003
- Application: ANDA040387
- Marketing authorisation holder: GENUS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 August 2003
- Application: ANDA076528
- Marketing authorisation holder: ABLE
- Local brand name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 August 2003
- Application: ANDA040513
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2003
- Application: ANDA040511
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2003
- Application: ANDA040496
- Marketing authorisation holder: MIKART
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2004
- Application: ANDA076560
- Marketing authorisation holder: LGM PHARMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 July 2005
- Application: ANDA040601
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2007
- Application: ANDA078149
- Marketing authorisation holder: MPP PHARMA
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 2008
- Application: ANDA040864
- Marketing authorisation holder: GRANULES
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2008
- Application: ANDA040883
- Marketing authorisation holder: MIRROR PHARMS LLC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2009
- Application: ANDA040885
- Marketing authorisation holder: LGM PHARMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 August 2011
- Application: ANDA090956
- Marketing authorisation holder: LGM PHARMA
- Status: approved
FDA — authorised 13 September 2012
- Application: ANDA200243
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA203335
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 September 2016
- Application: ANDA204195
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA207118
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 January 2017
- Application: ANDA204984
- Marketing authorisation holder: ALVOGEN
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2018
- Application: ANDA204733
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 September 2018
- Application: ANDA211106
- Marketing authorisation holder: ABHAI LLC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA212083
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA210817
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA212082
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA213321
- Marketing authorisation holder: GRANULES
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 2020
- Application: ANDA211543
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA203647
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 2021
- Application: ANDA214087
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 October 2021
- Application: ANDA205230
- Marketing authorisation holder: LGM PHARMA
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA215138
- Marketing authorisation holder: HIKMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 March 2022
- Application: ANDA215135
- Marketing authorisation holder: HIKMA
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 2022
- Application: ANDA214955
- Marketing authorisation holder: NE RX PHARMA
- Status: approved
FDA
- Application: ANDA088972
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087629
- Marketing authorisation holder: GILBERT LABS
- Local brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089448
- Marketing authorisation holder: HALSEY
- Local brand name: BUTALBITAL, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
Butalbital, Aspirin And Caffeine 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 Butalbital, Aspirin And Caffeine approved in United States?
Yes. FDA authorised it on 21 February 1979; FDA authorised it on 5 June 1979; FDA authorised it on 25 July 1979.
Who is the marketing authorisation holder for Butalbital, Aspirin And Caffeine in United States?
WATSON LABS holds the US marketing authorisation.