FDA — authorised 14 August 1986
- Application: ANDA070231
- Marketing authorisation holder: INWOOD LABS
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Antiepileptic drug therapy in United States
FDA authorised Antiepileptic drug therapy on 14 August 1986
Marketing authorisations
FDA — authorised 24 July 1987
- Application: ANDA071479
- Marketing authorisation holder: PLIVA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 1987
- Application: ANDA071696
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 1988
- Application: ANDA071940
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 25 March 1996
- Application: NDA020234
- Marketing authorisation holder: NOVARTIS
- Local brand name: TEGRETOL-XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 September 1996
- Application: ANDA074569
- Marketing authorisation holder: TEVA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 1996
- Application: ANDA074649
- Marketing authorisation holder: TARO
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1996
- Application: ANDA074869
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 1997
- Application: ANDA074979
- Marketing authorisation holder: SANDOZ
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1997
- Application: ANDA074925
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 1997
- Application: ANDA074940
- Marketing authorisation holder: QUAGEN
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1997
- Application: NDA020813
- Marketing authorisation holder: ROCHE
- Local brand name: KLONOPIN RAPIDLY DISINTEGRATING
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 December 1997
- Application: ANDA074964
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1998
- Application: ANDA074920
- Marketing authorisation holder: TEVA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 1998
- Application: ANDA075150
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2000
- Application: ANDA075468
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2000
- Application: ANDA075687
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 21 December 2000
- Application: ANDA075875
- Marketing authorisation holder: TARO
- Local brand name: CARBAMAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 February 2002
- Application: ANDA075948
- Marketing authorisation holder: APOTEX
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2003
- Application: ANDA076525
- Marketing authorisation holder: TARO
- Local brand name: TERIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 2004
- Application: ANDA076729
- Marketing authorisation holder: TARO
- Local brand name: TERIL
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 10 December 2004
- Application: NDA021710
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: EQUETRO
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 May 2005
- Application: ANDA077147
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2005
- Application: ANDA077171
- Marketing authorisation holder: PH HEALTH
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 10 August 2005
- Application: ANDA077194
- Marketing authorisation holder: BARR
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 June 2006
- Application: ANDA077856
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2009
- Application: ANDA078115
- Marketing authorisation holder: TARO
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 November 2011
- Application: ANDA078986
- Marketing authorisation holder: APOTEX INC
- Local brand name: CARBAMAZEPINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 September 2012
- Application: ANDA078592
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CARBAMAZEPINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 June 2013
- Application: ANDA201106
- Marketing authorisation holder: TARO
- Local brand name: CARBAMAZEPINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 August 2014
- Application: ANDA078654
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 7 October 2016
- Application: NDA206030
- Marketing authorisation holder: LUNDBECK PHARMS LLC
- Local brand name: CARNEXIV
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA211259
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA208785
- Marketing authorisation holder: HIKMA
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209808
- Marketing authorisation holder: PIRAMAL
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209718
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209795
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209440
- Marketing authorisation holder: TARO
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA211449
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209687
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA210039
- Marketing authorisation holder: AMNEAL
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209308
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA208819
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA208825
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209715
- Marketing authorisation holder: HIKMA
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA210569
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 November 2018
- Application: NDA210833
- Marketing authorisation holder: ASSERTIO SPECLTY
- Local brand name: SYMPAZAN
- Indication: FILM — ORAL
- Status: approved
FDA — authorised 14 December 2018
- Application: ANDA210545
- Marketing authorisation holder: LUPIN
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2018
- Application: ANDA210546
- Marketing authorisation holder: LUPIN
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 January 2019
- Application: ANDA211711
- Marketing authorisation holder: MICRO LABS
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2019
- Application: ANDA205571
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 May 2019
- Application: ANDA212398
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2019
- Application: ANDA211033
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA210746
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA212714
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA212092
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2020
- Application: ANDA211032
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA209796
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 April 2020
- Application: ANDA207798
- Marketing authorisation holder: UMEDICA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2020
- Application: ANDA213110
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 June 2020
- Application: ANDA209853
- Marketing authorisation holder: APOTEX
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2021
- Application: ANDA213311
- Marketing authorisation holder: CSPC OUYI
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 May 2021
- Application: ANDA213404
- Marketing authorisation holder: MSN
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 2021
- Application: ANDA214328
- Marketing authorisation holder: RK PHARMA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2021
- Application: ANDA212948
- Marketing authorisation holder: ANBISON LAB
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 March 2022
- Application: ANDA214404
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA215591
- Marketing authorisation holder: ZHEJIANG JIUZHOU
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA216594
- Marketing authorisation holder: UMEDICA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA213284
- Marketing authorisation holder: UNICHEM
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2022
- Application: ANDA216008
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 December 2022
- Application: ANDA216404
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA216235
- Marketing authorisation holder: SCIECURE PHARMA INC
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 March 2023
- Application: ANDA216193
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 September 2023
- Application: ANDA212704
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 February 2024
- Application: ANDA218221
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2024
- Application: ANDA213159
- Marketing authorisation holder: APOTEX
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 October 2024
- Application: ANDA215664
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 January 2025
- Application: ANDA212524
- Marketing authorisation holder: TORRENT
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 January 2025
- Application: ANDA217277
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 January 2025
- Application: ANDA219072
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 April 2025
- Application: ANDA216623
- Marketing authorisation holder: ALEMBIC
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2025
- Application: ANDA219939
- Marketing authorisation holder: ALEMBIC
- Local brand name: CARBAMAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA070300
- Marketing authorisation holder: USL PHARMA
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078746
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CARBAMAZEPINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA070429
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CARBAMAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Antiepileptic drug therapy 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 Antiepileptic drug therapy approved in United States?
Yes. FDA authorised it on 14 August 1986; FDA authorised it on 24 July 1987; FDA authorised it on 9 November 1987.
Who is the marketing authorisation holder for Antiepileptic drug therapy in United States?
INWOOD LABS holds the US marketing authorisation.