Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 205692
Company: ELI LILLY AND CO
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/2015/205692Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.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-Container/Carton Labels | 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-Patient Package Insert | 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-Container/Carton Labels | 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-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 |