FDA — authorised 30 December 1993
- Application: NDA020235
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Neurontin in United States
FDA authorised Neurontin on 30 December 1993
Marketing authorisations
FDA — authorised 9 October 1998
- Application: NDA020882
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2000
- Application: NDA021129
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 October 2000
- Application: NDA021216
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021423
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021424
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021397
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2003
- Application: ANDA075350
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 April 2004
- Application: ANDA076017
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 2004
- Application: ANDA075827
- Marketing authorisation holder: TEVA
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2005
- Application: ANDA075477
- Marketing authorisation holder: CSPC OUYI
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 2005
- Application: ANDA075360
- Marketing authorisation holder: GRANULES
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 2005
- Application: ANDA075539
- Marketing authorisation holder: SANDOZ
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 2005
- Application: ANDA076537
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 September 2005
- Application: ANDA076605
- Marketing authorisation holder: RANBAXY
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 October 2005
- Application: ANDA076606
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 January 2006
- Application: ANDA076120
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2006
- Application: ANDA076877
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2006
- Application: ANDA077662
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2006
- Application: ANDA077525
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2006
- Application: ANDA077242
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 September 2006
- Application: ANDA077661
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2007
- Application: ANDA075485
- Marketing authorisation holder: WATSON LABS
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 July 2007
- Application: ANDA078428
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 2007
- Application: ANDA078150
- Marketing authorisation holder: HIKMA
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 June 2010
- Application: ANDA090335
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2010
- Application: ANDA090858
- Marketing authorisation holder: ALKEM
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 February 2011
- Application: ANDA078926
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2011
- Application: ANDA090158
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2011
- Application: ANDA078974
- Marketing authorisation holder: MISSION PHARMACAL
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 July 2011
- Application: ANDA090007
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 March 2012
- Application: ANDA202024
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 May 2012
- Application: ANDA076403
- Marketing authorisation holder: ACELLA PHARMS LLC
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 July 2013
- Application: ANDA076672
- Marketing authorisation holder: TARO
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 July 2013
- Application: ANDA203244
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 2013
- Application: ANDA077261
- Marketing authorisation holder: TARO
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA206402
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 2016
- Application: ANDA205101
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 2016
- Application: ANDA204989
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: RELGAABI
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 March 2016
- Application: ANDA091286
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 March 2017
- Application: ANDA205807
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2017
- Application: ANDA207099
- Marketing authorisation holder: RISING
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 2017
- Application: ANDA091008
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 2017
- Application: ANDA207057
- Marketing authorisation holder: CSPC OUYI
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2018
- Application: ANDA206943
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 2018
- Application: ANDA209306
- Marketing authorisation holder: LUPIN
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA211314
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 December 2019
- Application: ANDA211330
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 August 2020
- Application: ANDA213603
- Marketing authorisation holder: ZHEJIANG YONGTAI
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 2021
- Application: ANDA214956
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2021
- Application: ANDA214957
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2023
- Application: ANDA216492
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GABAPENTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 March 2023
- Application: ANDA217116
- Marketing authorisation holder: GRANULES
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 May 2023
- Application: ANDA217546
- Marketing authorisation holder: LAURUS
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2023
- Application: ANDA217995
- Marketing authorisation holder: RISING
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2023
- Application: ANDA208928
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 January 2024
- Application: ANDA203934
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2024
- Application: ANDA216252
- Marketing authorisation holder: HUMANWELL
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2024
- Application: ANDA217965
- Marketing authorisation holder: LAURUS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA209855
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 2024
- Application: ANDA203643
- Marketing authorisation holder: ABON PHARMS LLC
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2025
- Application: ANDA219319
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 2025
- Application: ANDA218491
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA203611
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
Pricing & reimbursement
- annual_list: USD 1000000.00 per year
Neurontin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Neurontin approved in United States?
Yes. FDA authorised it on 30 December 1993; FDA authorised it on 9 October 1998; FDA authorised it on 2 March 2000.
Who is the marketing authorisation holder for Neurontin in United States?
VIATRIS holds the US marketing authorisation.
What does Neurontin cost in United States?
annual_list: USD 1000000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.