FDA — authorised 26 October 1998
- Application: NDA020844
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: TOPAMAX SPRINKLE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Quetiapine and Topiramate in United States
FDA authorised Quetiapine and Topiramate on 26 October 1998
Marketing authorisations
FDA — authorised 17 December 2003
- Application: ANDA076448
- Marketing authorisation holder: BARR
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA076311
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA077627
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA077643
- Marketing authorisation holder: WATSON LABS
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA078235
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA079153
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA076343
- Marketing authorisation holder: CIPLA LTD
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA090162
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA076327
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA090278
- Marketing authorisation holder: SUN PHARM
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA076317
- Marketing authorisation holder: TEVA
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA077733
- Marketing authorisation holder: PHARMACO
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA076314
- Marketing authorisation holder: NATCO
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2009
- Application: ANDA079162
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2009
- Application: ANDA076575
- Marketing authorisation holder: TEVA
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 October 2009
- Application: ANDA078418
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 October 2009
- Application: ANDA079206
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 October 2009
- Application: ANDA078877
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 September 2010
- Application: ANDA090353
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2013
- Application: ANDA078637
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 2013
- Application: ANDA078410
- Marketing authorisation holder: CHARTWELL
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2013
- Application: ANDA091185
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 2021
- Application: ANDA210278
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 August 2021
- Application: ANDA215414
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2022
- Application: ANDA208949
- Marketing authorisation holder: ZYDUS
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 February 2023
- Application: ANDA216167
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 March 2023
- Application: ANDA205976
- Marketing authorisation holder: PH HEALTH
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 August 2023
- Application: ANDA215663
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 September 2023
- Application: ANDA215449
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 December 2023
- Application: ANDA217694
- Marketing authorisation holder: TWI PHARMS
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 June 2024
- Application: ANDA218482
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 July 2024
- Application: ANDA215561
- Marketing authorisation holder: LUPIN
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 2024
- Application: ANDA217869
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 October 2024
- Application: ANDA218642
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA217795
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TOPIRAMATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 November 2024
- Application: ANDA215638
- Marketing authorisation holder: XIAMEN LP PHARM CO
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 December 2024
- Application: ANDA218695
- Marketing authorisation holder: AMTA
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 May 2025
- Application: ANDA216683
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: TOPIRAMATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 2025
- Application: ANDA219564
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 January 2026
- Application: ANDA217443
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: TOPIRAMATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA076306
- Marketing authorisation holder: ROXANE
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA076315
- Marketing authorisation holder: BARR
- Local brand name: TOPIRAMATE
- Indication: TABLET — ORAL
- Status: approved
Quetiapine and Topiramate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Psychiatry / Neurology approved in United States
Frequently asked questions
Is Quetiapine and Topiramate approved in United States?
Yes. FDA authorised it on 26 October 1998; FDA authorised it on 17 December 2003; FDA authorised it on 27 March 2009.
Who is the marketing authorisation holder for Quetiapine and Topiramate in United States?
JANSSEN PHARMS holds the US marketing authorisation.