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Details for New Drug Application (NDA): 208223

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NDA 208223 describes ZEMBRACE SYMTOUCH, which is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ZEMBRACE SYMTOUCH profile page.

The generic ingredient in ZEMBRACE SYMTOUCH is sumatriptan succinate. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for NDA: 208223

Dr Reddys Labs Ltd
sumatriptan succinate

Pharmacology for NDA: 208223

Suppliers and Packaging for NDA: 208223

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sumatriptan succinate
SOLUTION;SUBCUTANEOUS 208223 NDA Promius Pharma, LLC 67857-809 67857-809-38 4 SYRINGE in 1 CARTON (67857-809-38) > 1 INJECTION, SOLUTION in 1 SYRINGE (67857-809-37)

Summary 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:No

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