← FDA DRUG APPROVALS

FDA NDA · NDA208223

ZEMBRACE SYMTOUCH

sumatriptan succinate

Sponsor: TONIX MEDS

APPLICATION
NDA208223
TYPE
NDA
ORIGINAL APPROVAL
2016-01-28
LATEST ACTION
2019-06-10
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ZEMBRACE SYMTOUCH · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2019-06-10Efficacy · Supplement 5 · standard — Label ↗AP
2017-03-20Labeling · Supplement 3 · standard — Label ↗AP
2016-01-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →