Application Nr Approved Date Route Status External Links
NDA021231 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zolmitriptan Tablets And Zolmitriptan Orally Disintegrating Tablets Are Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults. Limitations Of Use • Only Use Zolmitriptan Tablets Or Zolmitriptan Orally Disintegrating Tablets If A Clear Diagnosis Of Migraine Has Been Established. If A Patient Has No Response To Zolmitriptan Tablets Or Zolmitriptan Orally Disintegrating Tablets Treatment For The First Migraine Attack, Reconsider The Diagnosis Of Migraine Before Zolmitriptan Tablets Or Zolmitriptan Orally Disintegrating Tablets Is Administered To Treat Any Subsequent Attacks. • Zolmitriptan Tablets And Zolmitriptan Orally Disintegrating Tablets Are Not Indicated For The Prevention Of Migraine Attacks. • Safety And Effectiveness Of Zolmitriptan Tablets And Zolmitriptan Orally Disintegrating Tablets Have Not Been Established For Cluster Headache. Zolmitriptan Is A Serotonin (5‑ht) 1b/1d Receptor Agonist (Triptan) Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults (1) Limitations Of Use : • Use Only After A Clear Diagnosis Of Migraine Has Been Established (1) • Not Indicated For The Prophylactic Therapy Of Migraine (1) • Not Indicated For The Treatment Of Cluster Headache (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zolmitriptan ZOLMITRIPTAN ZINC15515

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