Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 No No
TOUJEO SOLOSTAR INSULIN GLARGINE RECOMBINANT 450 UNITS/1.5ML (300 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No 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
02/25/2015 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
11/15/2019 SUPPL-13 Supplement

Label is not available on this site.

11/26/2019 SUPPL-12 Supplement

Label is not available on this site.

10/25/2018 SUPPL-11 Supplement

Label is not available on this site.

10/25/2018 SUPPL-10 Supplement

Label is not available on this site.

03/26/2018 SUPPL-6 Supplement

Label is not available on this site.

11/23/2016 SUPPL-3 Supplement

Label is not available on this site.

02/16/2016 SUPPL-2 Supplement

Label is not available on this site.

09/29/2015 SUPPL-1 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
11/15/2019 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
02/25/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf

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