Details for New Drug Application (NDA): 210884
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The generic ingredient in TOSYMRA is sumatriptan. There is one drug master file entry 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: | 9 |
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: | ⤷ Start Trial | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210884
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tonix Meds | TOSYMRA | sumatriptan | SPRAY;NASAL | 210884-001 | Jan 25, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Tonix Meds | TOSYMRA | sumatriptan | SPRAY;NASAL | 210884-001 | Jan 25, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Tonix Meds | TOSYMRA | sumatriptan | SPRAY;NASAL | 210884-001 | Jan 25, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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