FDA — authorised 25 November 1997
- Application: NDA020768
- Marketing authorisation holder: IPR
- Local brand name: ZOMIG
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Zomig in United States
FDA authorised Zomig on 25 November 1997
Marketing authorisations
FDA — authorised 25 November 1997
- Marketing authorisation holder: IPR
- Status: approved
FDA — authorised 13 February 2001
- Application: NDA021231
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ZOMIG-ZMT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 September 2003
- Application: NDA021450
- Marketing authorisation holder: AMNEAL
- Local brand name: ZOMIG
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 14 May 2013
- Application: ANDA202476
- Marketing authorisation holder: APOTEX INC
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 14 May 2013
- Application: ANDA203186
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2013
- Application: ANDA201779
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2013
- Application: ANDA202560
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 15 May 2013
- Application: ANDA202890
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 4 March 2014
- Application: ANDA090861
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2014
- Application: ANDA203476
- Marketing authorisation holder: SUN PHARMA GLOBAL
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2014
- Application: ANDA202279
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2015
- Application: ANDA202956
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 September 2015
- Application: ANDA203772
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2015
- Application: ANDA204232
- Marketing authorisation holder: ALEMBIC
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2015
- Application: ANDA204336
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 11 May 2016
- Application: ANDA207021
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 20 May 2016
- Application: ANDA204041
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 2016
- Application: ANDA205074
- Marketing authorisation holder: ALEMBIC
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 27 February 2017
- Application: ANDA207867
- Marketing authorisation holder: PLD ACQUISITIONS LLC
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2017
- Application: ANDA206973
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2018
- Application: ANDA203019
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 2019
- Application: ANDA202855
- Marketing authorisation holder: RISING
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA203726
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: ZOLMITRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2020
- Application: ANDA204284
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 30 September 2021
- Application: ANDA212469
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ZOLMITRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
Zomig 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 Zomig approved in United States?
Yes. FDA authorised it on 25 November 1997; FDA authorised it on 25 November 1997; FDA authorised it on 13 February 2001.
Who is the marketing authorisation holder for Zomig in United States?
IPR holds the US marketing authorisation.