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
AIRDUO DIGIHALER از شرکت TEVA PHARM
New Drug Application (NDA): 208799
Company: TEVA PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
Yes | No |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
Yes | No |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
Yes | No |
| AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
Yes | No |
| AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
Yes | No |
| AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER;INHALATION | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 01/27/2017 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/09/2021 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208799Orig1s021ltr.pdf |
||
| 02/21/2020 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208799Orig1s011ltr.pdf |
||
| 12/20/2017 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s002ltr.pdf |
||
| 03/02/2018 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208798Orig1s002,208799Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/09/2021 | SUPPL-21 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf | |
| 02/21/2020 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf | |
| 03/02/2018 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf | |
| 12/20/2017 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf | |
| 01/27/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf |
نظرات کاربران