Application Nr Approved Date Route Status External Links
ANDA077744 2009-08-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sumatriptan Tablets, Usp 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 Tablets, Reconsider The Diagnosis Of Migraine Before Sumatriptan Tablets Are Administered To Treat Any Subsequent Attacks. •sumatriptan Tablets Are Not Indicated For The Prevention Of Migraine Attacks. •safety And Effectiveness Of Sumatriptan Tablets Have Not Been Established For Cluster Headache. Sumatriptan Tablets Are A Serotonin (5-Ht1b/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 (10 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Povidones POVIDONES Unresolved
10. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sumatriptan Succinate SUMATRIPTAN SUCCINATE ZINC14360

Comments