Application Nr Approved Date Route Status External Links
ANDA078295 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sumatriptan Succinate Tablets Are 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 Succinate Tablets, Reconsider The Diagnosis Of Migraine Before Sumatriptan Succinate Tablets Are Administered To Treat Any Subsequent Attacks. • Sumatriptan Succinate Tablets Are Not Indicated For The Prevention Of Migraine Attacks. • Safety And Effectiveness Of Sumatriptan Succinate Tablets Have Not Been Established For Cluster Headache. Sumatriptan Succinate 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 Succinate SUMATRIPTAN SUCCINATE ZINC14360

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