Application Nr Approved Date Route Status External Links
ANDA204841 None Nasal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sumatriptan Nasal Spray, Usp Is Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults. Limitations Of Use: Use Only If A Clear Diagnosis Of Migraine Headache Has Been Established. If A Patient Has No Response To The First Migraine Attack Treated With Sumatriptan, Reconsider The Diagnosis Of Migraine Before Sumatriptan Is Administered To Treat Any Subsequent Attacks. Sumatriptan Is Not Indicated For The Prevention Of Migraine Attacks. Safety And Effectiveness Of Sumatriptan Nasal Spray, Usp Have Not Been Established For Cluster Headache. Sumatriptan Is A Serotonin (5-Ht 1b/1d ) Receptor Agonist (Triptan) Indicated For Acute Treatment Of Migraine With Or Without Aura In Adults. ( 1 ) Limitations Of Use: Use Only If A Clear Diagnosis Of Migraine Headache Has Been Established. ( 1 ) Not Indicated For The Prophylactic Therapy Of Migraine Attacks. ( 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. Sumatriptan SUMATRIPTAN ZINC14360

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