FDA — authorised 22 January 2009
- Application: ANDA078009
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: LAMOTRIGINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Lamictal in United States
FDA authorised Lamictal on 22 January 2009
Marketing authorisations
FDA — authorised 27 January 2009
- Application: ANDA078956
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA077428
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA078645
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA079132
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA077633
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA078525
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA078947
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA078625
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA077420
- Marketing authorisation holder: RISING
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 2009
- Application: ANDA079204
- Marketing authorisation holder: TARO
- Local brand name: LAMOTRIGINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 February 2009
- Application: ANDA078310
- Marketing authorisation holder: ZENNOVA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 January 2011
- Application: ANDA090607
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2011
- Application: ANDA078669
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2011
- Application: ANDA090170
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 2012
- Application: ANDA090169
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2013
- Application: ANDA202498
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 January 2013
- Application: ANDA201791
- Marketing authorisation holder: PH HEALTH
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 June 2013
- Application: ANDA200694
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2013
- Application: ANDA202887
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 July 2013
- Application: ANDA200828
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: LAMOTRIGINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 17 October 2013
- Application: ANDA200672
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2013
- Application: ANDA203370
- Marketing authorisation holder: TORRENT
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 June 2016
- Application: ANDA206382
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LAMOTRIGINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA207497
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2021
- Application: ANDA213271
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: LAMOTRIGINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 8 December 2021
- Application: ANDA213949
- Marketing authorisation holder: YILING
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 February 2022
- Application: ANDA214124
- Marketing authorisation holder: AMRING PHARMS
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA204499
- Marketing authorisation holder: IPCA LABS
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 2024
- Application: ANDA211821
- Marketing authorisation holder: ALEMBIC
- Local brand name: LAMOTRIGINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 September 2025
- Application: NDA218879
- Marketing authorisation holder: OWP PHARMS
- Local brand name: SUBVENITE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 January 2026
- Application: ANDA217100
- Marketing authorisation holder: TORRENT
- Status: approved
FDA — authorised 25 February 2026
- Application: ANDA217278
- Marketing authorisation holder: ALEMBIC
- Local brand name: LAMOTRIGINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
The FDA approved Lamictal (Lamotrigine) orally disintegrating tablets for marketing by Alembic on February 25, 2026. This approval was granted under the standard expedited pathway. The orally disintegrating tablets are indicated for the treatment of epilepsy and bipolar disorder.
FDA
- Application: ANDA077757
- Marketing authorisation holder: CARACO
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077392
- Marketing authorisation holder: ROXANE
- Local brand name: LAMOTRIGINE
- Indication: TABLET — ORAL
- Status: approved
Lamictal 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 Lamictal approved in United States?
Yes. FDA authorised it on 22 January 2009; FDA authorised it on 27 January 2009; FDA authorised it on 27 January 2009.
Who is the marketing authorisation holder for Lamictal in United States?
ZYDUS PHARMS USA INC holds the US marketing authorisation.