Regulatory PathRegulatory requirements compared

Active substance

Zolmitriptan

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ZOMIG2.5MG/SPRAY; 5MG/SPRAYspray · nasalAMNEALPrescription30 Sep 2003
ZOLMITRIPTAN2.5MG; 5MGtablet · oralGLENMARK PHARMS LTDPrescription14 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralGLENMARK PHARMS LTDPrescription14 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralZYDUS PHARMS USA INCPrescription15 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet · oralJUBILANT GENERICSPrescription20 Nov 2014
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralJUBILANT GENERICSPrescription17 Sep 2015
ZOLMITRIPTAN2.5MG; 5MGtablet · oralALEMBICPrescription30 Sep 2015
ZOLMITRIPTAN2.5MG; 5MGtablet · oralAUROBINDO PHARMAPrescription11 May 2016
ZOLMITRIPTAN2.5MG; 5MGtablet · oralAJANTA PHARMA LTDPrescription20 May 2016
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralALEMBICPrescription1 Dec 2016
ZOLMITRIPTAN2.5MG; 5MGtablet · oralPLD ACQUISITIONS LLCPrescription27 Feb 2017
ZOLMITRIPTAN2.5MG; 5MGtablet · oralCHARTWELL RXPrescription30 Jun 2017
ZOLMITRIPTAN2.5MG; 5MGtablet · oralZYDUS PHARMSPrescription11 Jul 2018
ZOLMITRIPTAN2.5MG; 5MGtablet · oralORBION PHARMSPrescription21 Oct 2019
ZOLMITRIPTAN2.5MG/SPRAY; 5MG/SPRAYspray · nasalPADAGIS ISRAELPrescription30 Sep 2021
ZOMIG2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralIPRDiscontinued25 Nov 1997
ZOMIG-ZMT2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, orally disintegrating · oralASTRAZENECADiscontinued13 Feb 2001
ZOLMITRIPTAN2.5MG; 5MGtablet · oralAPOTEX INCDiscontinued14 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralAPOTEX INCDiscontinued14 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet · oralNATCO PHARMA USADiscontinued14 May 2013
ZOLMITRIPTAN2.5MG; 5MGtablet · oralANI PHARMSDiscontinued4 Mar 2014
ZOLMITRIPTAN2.5MG; 5MGtablet · oralINVAGEN PHARMSDiscontinued9 Apr 2014
ZOLMITRIPTAN2.5MG; 5MGtablet · oralSUN PHARMA GLOBALDiscontinued13 Nov 2014
ZOLMITRIPTAN2.5MG; 5MGtablet · oralMACLEODS PHARMSDiscontinued30 Sep 2015
ZOLMITRIPTAN2.5MG; 5MGtablet, orally disintegrating · oralMACLEODS PHARMSDiscontinued22 Oct 2015

1 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-ZOLMITRIPTAN024810302.5 MGTABLET · ORALAURO PHARMA INC
BIO-ZOLMITRIPTAN025128312.5 MGTABLET · ORALBIOMED PHARMA
JAMP-ZOLMITRIPTAN024216232.5 MGTABLET · ORALJAMP PHARMA CORPORATION
M-ZOLMITRIPTAN025661332.5 MGTABLET · ORALMANTRA PHARMA INC
MAR-ZOLMITRIPTAN023994582.5 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-ZOLMITRIPTAN024195212.5 MGTABLET · ORALMINT PHARMACEUTICALS INC
NAT-ZOLMITRIPTAN024215342.5 MGTABLET · ORALNATCO PHARMA (CANADA) INC
NRA-ZOLMITRIPTAN024893922.5 MGTABLET · ORALNORA PHARMA INC
SANDOZ ZOLMITRIPTAN023629882.5 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ ZOLMITRIPTAN ODT023629962.5 MGTABLET (ORALLY-DISINTEGRATING) · ORALSANDOZ CANADA INCORPORATED
TEVA-ZOLMITRIPTAN023139602.5 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-ZOLMITRIPTAN OD023425452.5 MGTABLET (ORALLY-DISINTEGRATING) · ORALTEVA CANADA LIMITED
ZOMIG022386602.5 MGTABLET · ORALXEDITON PHARMACEUTICALS INC
ZOMIG NASAL SPRAY022489922.5 MG / ACTSPRAY · NASAL; ORALXEDITON PHARMACEUTICALS INC
ZOMIG NASAL SPRAY022489935 MG / ACTSPRAY · ORAL; NASALXEDITON PHARMACEUTICALS INC
ZOMIG RAPIMELT022430452.5 MGTABLET (ORALLY-DISINTEGRATING) · ORALXEDITON PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACZOLMITRIPTAN 2.5 MG ODT$2.06825per EA23 Sep 2026
US NADACZOLMITRIPTAN 2.5 MG TABLET$1.0228per EA23 Sep 2026
US NADACZOLMITRIPTAN 5 MG NASAL SPRAY$44.03928per EA23 Sep 2026
US NADACZOLMITRIPTAN 5 MG ODT$3.24791per EA23 Sep 2026
US NADACZOLMITRIPTAN 5 MG TABLET$1.35334per EA23 Sep 2026
US NADACZOMIG 2.5 MG NASAL SPRAY$108.56466per EA18 Feb 2026
US NADACZOMIG 5 MG NASAL SPRAY$108.8863per EA23 Sep 2026
NHS Drug TariffZolmitriptan 2.5mg orodispersible tablets sugar free£3.076 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 2.5mg tablets£30.436 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 2.5mg tablets£60.8712 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 5mg orodispersible tablets sugar free£3.636 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 5mg tablets£36.006 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 5mg tablets£72.0012 tablet1 Oct 2026
NHS Drug TariffZolmitriptan 5mg/0.1ml nasal spray unit dose£42.476 unit dose1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for zolmitriptan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.