Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202278
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZECUITY SUMATRIPTAN SUCCINATE EQ 6.5MG BASE/4HR SYSTEM;IONTOPHORESIS Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/07/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/17/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/21/2014 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf
03/21/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2014 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf
03/21/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf
01/17/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf

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