Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022239
Company: ENDO VENTURES LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMAVEL DOSEPRO SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Discontinued None Yes No
SUMAVEL DOSEPRO SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS 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
07/15/2009 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/2009/022239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022239s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239_sumavel_dosepro_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239s000Sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2013 SUPPL-5 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022239Orig1s005ltr.pdf
06/02/2016 SUPPL-4 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf
06/27/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022239s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2016 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf
11/26/2013 SUPPL-5 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf
06/27/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf
07/15/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf

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