Application Nr Approved Date Route Status External Links
ANDA204284 2014-04-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Zolmitriptan Tablets Are Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults. Limitations Of Use Only Use Zolmitriptan Tablets If A Clear Diagnosis Of Migraine Has Been Established. If A Patient Has No Response To Zolmitriptan Tablets Treatment For The First Migraine Attack, Reconsider The Diagnosis Of Migraine Before Zolmitriptan Tablets Are Administered To Treat Any Subsequent Attacks. Zolmitriptan Tablets Are Not Indicated For The Prevention Of Migraine Attacks. Safety And Effectiveness Of Zolmitriptan Tablets Have Not Been Established For Cluster Headache. Zolmitriptan Tablets Are 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 (6 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular

Active Ingredients ( 1 Total)

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

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