Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208673
Company: SANOFI-AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLIQUA 100/33 INSULIN GLARGINE; LIXISENATIDE 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/21/2016 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208673Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2019 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s007ltr.pdf
09/28/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208673Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2019 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf
08/29/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf
11/21/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf

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