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
ADMELOG از شرکت SANOFI-AVENTIS US
Biologic License Application (BLA): 209196
Company: SANOFI-AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADMELOG | INSULIN LISPRO | 1000 UNITS/10ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription |
None |
No | No |
| ADMELOG | INSULIN LISPRO | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription |
None |
No | No |
| ADMELOG SOLOSTAR | INSULIN LISPRO | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, 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 |
|---|---|---|---|---|---|---|---|
| 12/11/2017 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/15/2019 | SUPPL-5 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf |
||
| 11/15/2019 | SUPPL-4 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf |
||
| 11/01/2018 | SUPPL-2 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209196Orig1s002ltr.pdf |
||
| 10/19/2018 | 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-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf | |
| 11/15/2019 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf | |
| 11/01/2018 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf | |
| 12/11/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf |
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