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
BETHKIS از شرکت CHIESI
New Drug Application (NDA): 201820
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETHKIS | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription |
AN |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/12/2012 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/09/2019 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201820s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201820Orig1s005ltr.pdf |
||
| 05/29/2017 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201820s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201820Orig1s003ltr.pdf |
||
| 02/16/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/09/2019 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201820s005lbl.pdf | |
| 05/29/2017 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201820s003lbl.pdf | |
| 10/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf |
BETHKIS
SOLUTION;INHALATION; 300MG/4ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETHKIS | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription | Yes | AN | 201820 | CHIESI |
| TOBRAMYCIN | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription | No | AN | 210915 | TEVA PHARMS USA |
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