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Last Updated: November 22, 2024

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 two 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-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
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:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)
Approval Date:Jan 28, 2016TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 29, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MIGRAINE
Patent:⤷  Sign UpPatent Expiration:Jan 29, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MIGRAINE

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