FDA — authorised 11 October 2017
- Application: NDA209501
- Marketing authorisation holder: UPJOHN
- Local brand name: LYRICA CR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 paracetamol + pregabalin + dexamethasone in United States
FDA authorised paracetamol + pregabalin + dexamethasone on 11 October 2017
Marketing authorisations
FDA — authorised 19 July 2019
- Application: ANDA091219
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA203459
- Marketing authorisation holder: ALEMBIC
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA209664
- Marketing authorisation holder: DR REDDYS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA207799
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA207623
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: PREGABALIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA211384
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA209357
- Marketing authorisation holder: MSN
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA208677
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA091224
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA210432
- Marketing authorisation holder: RISING
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2019
- Application: ANDA209743
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 September 2019
- Application: ANDA091228
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 2019
- Application: ANDA210891
- Marketing authorisation holder: YILING
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 October 2019
- Application: ANDA206912
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA091157
- Marketing authorisation holder: SUN PHARM
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 December 2019
- Application: ANDA210585
- Marketing authorisation holder: RENATA
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 January 2020
- Application: ANDA212280
- Marketing authorisation holder: CIPLA
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 March 2020
- Application: ANDA212865
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 2020
- Application: ANDA091025
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 April 2021
- Application: ANDA213226
- Marketing authorisation holder: MSN
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 April 2021
- Application: ANDA213313
- Marketing authorisation holder: APOTEX
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 April 2021
- Application: ANDA211889
- Marketing authorisation holder: SUN PHARM
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 April 2021
- Application: ANDA211593
- Marketing authorisation holder: ALVOGEN
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 July 2021
- Application: ANDA211431
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 July 2021
- Application: ANDA211687
- Marketing authorisation holder: ALVOGEN
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 July 2021
- Application: ANDA211685
- Marketing authorisation holder: APOTEX
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 July 2021
- Application: ANDA214322
- Marketing authorisation holder: CHANGZHOU PHARM
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA212604
- Marketing authorisation holder: PATRIN
- Local brand name: PREGABALIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 March 2022
- Application: ANDA212988
- Marketing authorisation holder: ESKAYEF
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 March 2022
- Application: ANDA215249
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 2022
- Application: ANDA216197
- Marketing authorisation holder: ADAPTIS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 August 2022
- Application: ANDA215577
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 September 2022
- Application: ANDA207883
- Marketing authorisation holder: PRINSTON INC
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 September 2022
- Application: ANDA215675
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 December 2022
- Application: ANDA206752
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA205321
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA215755
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 June 2023
- Application: ANDA214496
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 July 2023
- Application: ANDA206452
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 January 2024
- Application: ANDA209883
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 May 2024
- Application: ANDA208113
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 November 2024
- Application: ANDA205924
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 2025
- Application: ANDA217857
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: PREGABALIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 February 2025
- Application: ANDA206942
- Marketing authorisation holder: TORRENT
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 February 2025
- Application: ANDA091222
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA209530
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 2026
- Application: ANDA218529
- Marketing authorisation holder: FOURRTS LABS
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 2026
- Application: ANDA219593
- Marketing authorisation holder: UNICHEM
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA091229
- Marketing authorisation holder: SANDOZ INC
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA201989
- Marketing authorisation holder: LUPIN LTD
- Local brand name: PREGABALIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA202998
- Marketing authorisation holder: APOTEX INC
- Local brand name: PREGABALIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA091221
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA202269
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: PREGABALIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA203022
- Marketing authorisation holder: APOTEX INC
- Local brand name: PREGABALIN
- Indication: CAPSULE — ORAL
- Status: approved
paracetamol + pregabalin + dexamethasone 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 paracetamol + pregabalin + dexamethasone approved in United States?
Yes. FDA authorised it on 11 October 2017; FDA authorised it on 19 July 2019; FDA authorised it on 19 July 2019.
Who is the marketing authorisation holder for paracetamol + pregabalin + dexamethasone in United States?
UPJOHN holds the US marketing authorisation.