FDA — authorised 28 April 2004
- Application: ANDA076017
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Neurontin in United States
FDA authorised Neurontin on 28 April 2004
Marketing authorisations
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: 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 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 17 December 2010
- Application: ANDA090858
- Marketing authorisation holder: ALKEM
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 2011
- Application: NDA022544
- Marketing authorisation holder: ALMATICA
- Local brand name: GRALISE
- Indication: TABLET — 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 12 July 2013
- Application: ANDA203244
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: GABAPENTIN
- Indication: TABLET — 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 26 October 2017
- Application: ANDA207057
- Marketing authorisation holder: CSPC OUYI
- Local brand name: GABAPENTIN
- Indication: TABLET — 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
- 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 17 July 2023
- Application: ANDA217546
- Marketing authorisation holder: LAURUS
- Indication: Labeling
- 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 8 April 2024
- Application: ANDA217965
- Marketing authorisation holder: LAURUS
- 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 27 December 2024
- Application: ANDA217995
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
The FDA approved Neurontin for labeling indication on 2024-12-27. The marketing authorization holder is RISING. This approval was granted under the standard expedited pathway.
FDA — authorised 7 August 2025
- Application: ANDA219319
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: GABAPENTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA203611
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: GABAPENTIN
- Indication: TABLET — ORAL
- Status: approved
Neurontin 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 Neurontin approved in United States?
Yes. FDA authorised it on 28 April 2004; FDA authorised it on 15 December 2004; FDA authorised it on 23 March 2005.
Who is the marketing authorisation holder for Neurontin in United States?
IVAX SUB TEVA PHARMS holds the US marketing authorisation.