Details for New Drug Application (NDA): 208223
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NDA 208223 describes ZEMBRACE SYMTOUCH, which is a drug marketed by Tonix Meds and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ZEMBRACE SYMTOUCH profile page.
The generic ingredient in ZEMBRACE SYMTOUCH is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
The generic ingredient in ZEMBRACE SYMTOUCH is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 208223
| Tradename: | ZEMBRACE SYMTOUCH |
| Applicant: | Tonix Meds |
| Ingredient: | sumatriptan succinate |
| Patents: | 3 |
Pharmacology for NDA: 208223
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 208223
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEMBRACE SYMTOUCH | sumatriptan succinate | SOLUTION;SUBCUTANEOUS | 208223 | NDA | Upsher-Smith laboratories, LLC | 0245-0809 | 0245-0809-38 | 4 SYRINGE in 1 CARTON (0245-0809-38) / 1 INJECTION, SOLUTION in 1 SYRINGE (0245-0809-89) |
| ZEMBRACE SYMTOUCH | sumatriptan succinate | SOLUTION;SUBCUTANEOUS | 208223 | NDA | Tonix Medicines, Inc. | 70792-809 | 70792-809-38 | 4 BLISTER PACK in 1 CARTON (70792-809-38) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | ||||
| Approval Date: | Jan 28, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,537,554 | Patent Expiration: | Jan 29, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MIGRAINE | ||||||||
| Patent: | 11,364,224 | Patent Expiration: | Jan 29, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MIGRAINE | ||||||||
| Patent: | 12,097,183 | Patent Expiration: | Jan 29, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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