Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206538
Company: SANOFI US SERVICES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOUJEO MAX SOLOSTAR INSULIN GLARGINE RECOMBINANT 900 UNITS/3ML (300 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
TOUJEO SOLOSTAR INSULIN GLARGINE RECOMBINANT 450 UNITS/1.5ML (300 UNITS/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
02/25/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2018 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
03/26/2018 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206538Orig1s006ltr.pdf
11/23/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/29/2015 SUPPL-1 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2018 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
03/26/2018 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
03/26/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
03/26/2018 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
09/29/2015 SUPPL-1 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s001lbl.pdf
02/25/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf

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