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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208223
Company: TONIX MEDS

Products on NDA 208223

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208223Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208223Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208223Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2019	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208223s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208223Orig1s005ltr.pdf
03/20/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208223Orig1s003lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208223Orig1s003ltredt.pdf

Labels for NDA 208223

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2019	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208223s005lbl.pdf
03/20/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208223Orig1s003lbledt.pdf
01/28/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208223Orig1s000lbl.pdf

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