اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BASAGLAR از شرکت ELI LILLY AND CO
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/20/2021 | SUPPL-33 | Supplement |
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 |
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 |
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 |
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 |
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 |
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-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 | |
| 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-Patient 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 | |
| 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 |
نظرات کاربران