Details for New Drug Application (NDA): 208223
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The generic ingredient in ZEMBRACE SYMTOUCH is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-five 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: | 2 |
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: | ⤷ Sign Up | Patent Expiration: | Jan 29, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MIGRAINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 29, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MIGRAINE |
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