FDA — authorised 15 January 2009
- Application: ANDA078526
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Keppra in United States
FDA authorised Keppra on 15 January 2009
Marketing authorisations
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: ANDA078582
- Marketing authorisation holder: STRIDES PHARMA
- 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: ANDA078858
- Marketing authorisation holder: TORRENT PHARMS
- 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: ANDA078042
- Marketing authorisation holder: STRIDES PHARMA
- 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 16 January 2009
- Application: ANDA079120
- Marketing authorisation holder: BIONPHARMA
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — 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
The FDA approved Keppra for use in the United States on 2026-04-08. The marketing authorisation holder is CHARTWELL MOLECULAR. The approval was granted through the standard expedited pathway.
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 8 December 2009
- Application: ANDA090261
- Marketing authorisation holder: MYLAN
- Local brand name: LEVETIRACETAM
- Indication: TABLET — ORAL
- Status: approved
Mylan obtained marketing authorisation for Keppra from the FDA on February 10, 2025. The approval was granted under standard expedited pathway. The indication approved is for the drug's labeling, which is not specified in the provided information.
FDA — authorised 1 February 2010
- Application: ANDA078960
- Marketing authorisation holder: TARO
- Local brand name: LEVETIRACETAM
- Indication: TABLET — 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 5 August 2011
- Application: ANDA090187
- Marketing authorisation holder: APOTEX INC
- Local brand name: LEVETIRACETAM
- Indication: SOLUTION — 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 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: ANDA091430
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — 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: ANDA091261
- Marketing authorisation holder: APOTEX INC
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
APOTEX INC received marketing authorisation for Keppra from the FDA on 2024-04-23. The approval was granted under application number ANDA091261. Keppra is indicated for use as described in its labelling.
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 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 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 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 25 February 2015
- Application: ANDA202958
- Marketing authorisation holder: APOTEX
- Local brand name: LEVETIRACETAM
- Indication: TABLET, EXTENDED RELEASE — 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
- 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 22 May 2023
- Application: ANDA201157
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- 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 8 May 2026
- Application: ANDA218364
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: LEVETIRACETAM IN SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Keppra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Keppra approved in United States?
Yes. FDA authorised it on 15 January 2009; FDA authorised it on 15 January 2009; FDA authorised it on 15 January 2009.
Who is the marketing authorisation holder for Keppra in United States?
ORBION PHARMS holds the US marketing authorisation.