Details for New Drug Application (NDA): 210884
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NDA 210884 describes TOSYMRA, which is a drug marketed by Tonix Meds and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug. Additional details are available on the TOSYMRA profile page.
The generic ingredient in TOSYMRA is sumatriptan. There are twenty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
The generic ingredient in TOSYMRA is sumatriptan. There are twenty-four drug master file entries for this compound. Ten 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 |
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) |
| TOSYMRA | sumatriptan | SPRAY;NASAL | 210884 | NDA | Tonix Medicines, Inc. | 70792-812 | 70792-812-59 | 1 BLISTER PACK in 1 CARTON (70792-812-59) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY |
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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