FDA — authorised 30 November 1999
- Application: NDA021035
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 AGB101 in United States
FDA authorised AGB101 on 30 November 1999
Marketing authorisations
FDA — authorised 15 July 2003
- Application: NDA021505
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 July 2006
- Application: NDA021872
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 November 2008
- Application: ANDA076919
- Marketing authorisation holder: MYLAN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078101
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078976
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078234
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA076920
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078154
- Marketing authorisation holder: LUPIN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078993
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA090025
- Marketing authorisation holder: LUPIN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA079063
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078858
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA079042
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078042
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078904
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA077324
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078582
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA078526
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 2009
- Application: ANDA079120
- Marketing authorisation holder: BIONPHARMA
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 February 2009
- Application: ANDA078731
- Marketing authorisation holder: MYLAN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2009
- Application: ANDA078106
- Marketing authorisation holder: PRINSTON INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2009
- Application: ANDA077408
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 March 2009
- Application: ANDA078869
- Marketing authorisation holder: VIWIT PHARM
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 2009
- Application: ANDA077319
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2009
- Application: ANDA090263
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 April 2009
- Application: ANDA078918
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2009
- Application: ANDA090992
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 December 2009
- Application: ANDA090261
- Marketing authorisation holder: MYLAN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 2010
- Application: ANDA078960
- Marketing authorisation holder: TARO
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2010
- Application: ANDA090028
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 May 2010
- Application: ANDA090813
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 June 2010
- Application: ANDA090754
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 July 2010
- Application: ANDA090767
- Marketing authorisation holder: RISING
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2010
- Application: ANDA090484
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2010
- Application: ANDA090461
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 October 2010
- Application: ANDA090515
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2010
- Application: ANDA090906
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2010
- Application: ANDA091491
- Marketing authorisation holder: ZHEJIANG JINGXIN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2011
- Application: ANDA090843
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2011
- Application: ANDA201293
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2011
- Application: ANDA091485
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 August 2011
- Application: ANDA090187
- Marketing authorisation holder: APOTEX INC
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 August 2011
- Application: ANDA090511
- Marketing authorisation holder: MPP PHARMA
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091093
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091430
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091291
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091285
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091261
- Marketing authorisation holder: APOTEX INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2011
- Application: ANDA091557
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 October 2011
- Application: ANDA091360
- Marketing authorisation holder: PH HEALTH
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 October 2011
- Application: ANDA090981
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 October 2011
- Application: ANDA090893
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 November 2011
- Application: NDA202543
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 December 2011
- Application: ANDA200475
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 2012
- Application: ANDA202143
- Marketing authorisation holder: AM REGENT
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 February 2012
- Application: ANDA090601
- Marketing authorisation holder: HIKMA
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 April 2012
- Application: ANDA202869
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 May 2012
- Application: ANDA091338
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 July 2012
- Application: ANDA202533
- Marketing authorisation holder: PRINSTON INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 August 2012
- Application: ANDA202524
- Marketing authorisation holder: ROUSES POINT PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 November 2012
- Application: ANDA091668
- Marketing authorisation holder: SANDOZ
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2013
- Application: ANDA203052
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 May 2013
- Application: ANDA203067
- Marketing authorisation holder: ALEMBIC
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 June 2013
- Application: ANDA091627
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 September 2013
- Application: ANDA203059
- Marketing authorisation holder: SUN PHARM
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 February 2015
- Application: ANDA202958
- Marketing authorisation holder: APOTEX
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA203468
- Marketing authorisation holder: PRINSTON INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 June 2015
- Application: ANDA201157
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 July 2015
- Application: NDA207958
- Marketing authorisation holder: APRECIA PHARMS
- Local brand name: SPRITAM
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 August 2015
- Application: ANDA090876
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 September 2015
- Application: ANDA202167
- Marketing authorisation holder: ADAPTIS
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 December 2015
- Application: ANDA205102
- Marketing authorisation holder: CHINA RESOURCES
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2016
- Application: ANDA204511
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 June 2016
- Application: ANDA206838
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 June 2016
- Application: ANDA202095
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 August 2016
- Application: ANDA204754
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 September 2016
- Application: ANDA203308
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 January 2017
- Application: ANDA207160
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 September 2017
- Application: ANDA207175
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 October 2017
- Application: ANDA206880
- Marketing authorisation holder: GLAND
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 March 2018
- Application: ANDA209781
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 December 2018
- Application: NDA204417
- Marketing authorisation holder: TRIPOINT
- Local brand name: ELEPSIA XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA213532
- Marketing authorisation holder: NEXUS
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 November 2020
- Application: ANDA205130
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 March 2022
- Application: ANDA209474
- Marketing authorisation holder: PRINSTON INC
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 15 July 2022
- Application: ANDA214757
- Marketing authorisation holder: MSN
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 October 2022
- Application: ANDA214815
- Marketing authorisation holder: MSN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA215980
- Marketing authorisation holder: MSN
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 January 2023
- Application: ANDA208619
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 June 2023
- Application: ANDA217878
- Marketing authorisation holder: GRANULES
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2023
- Application: ANDA217059
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 February 2024
- Application: ANDA211356
- Marketing authorisation holder: HIKMA
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 February 2024
- Application: ANDA209705
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 January 2025
- Application: ANDA219562
- Marketing authorisation holder: CAPLIN
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 2 December 2025
- Application: ANDA215465
- Marketing authorisation holder: KNACK
- Local brand name: LEVETIRACETAM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 May 2026
- Application: ANDA218364
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Other Neurology approved in United States
Frequently asked questions
Is AGB101 approved in United States?
Yes. FDA authorised it on 30 November 1999; FDA authorised it on 15 July 2003; FDA authorised it on 31 July 2006.
Who is the marketing authorisation holder for AGB101 in United States?
UCB INC holds the US marketing authorisation.