Details for New Drug Application (NDA): 210884
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The generic ingredient in TOSYMRA is sumatriptan. There are twenty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
Summary for 210884
Tradename: | TOSYMRA |
Applicant: | Tonix Meds |
Ingredient: | sumatriptan |
Patents: | 8 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210884
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210884
Suppliers and Packaging for NDA: 210884
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOSYMRA | sumatriptan | SPRAY;NASAL | 210884 | NDA | Upsher-Smith Laboratories, LLC | 0245-0812 | 0245-0812-61 | 6 BLISTER PACK in 1 CARTON (0245-0812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK (0245-0812-89) / .1 mL in 1 BOTTLE, SPRAY (0245-0812-59) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 10MG/SPRAY | ||||
Approval Date: | Jan 25, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | ACUTE TREATMENT OF MIGRAINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | ACUTE TREATMENT OF MIGRAINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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