Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 205692
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BASAGLAR INSULIN GLARGINE 300 UNITS/3ML (100 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
12/16/2015 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Letter (PDF)
Review
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2021 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205692Orig1s033ltr.pdf
11/15/2019 SUPPL-25 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
11/15/2019 SUPPL-24 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
11/15/2019 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
09/05/2018 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205692s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205692Orig1s019ltr.pdf
06/01/2016 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s005ltr.pdf
06/17/2016 SUPPL-2 Supplement

Label is not available on this site.

06/17/2016 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
07/20/2021 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
07/20/2021 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
07/20/2021 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
11/15/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
09/05/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205692s019lbl.pdf
06/01/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf
12/16/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf

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