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
COMBIVENT RESPIMAT از شرکت BOEHRINGER INGELHEIM
New Drug Application (NDA): 021747
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMBIVENT RESPIMAT | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.1MG BASE/INH;0.02MG/INH | SPRAY, METERED;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 |
|---|---|---|---|---|---|---|---|
| 10/07/2011 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2020 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021747s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021747Orig1s020ltr.pdf |
||
| 06/17/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2016 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s013ltr.pdf |
||
| 04/15/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2016 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf |
||
| 07/09/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf |
||
| 06/19/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/2012 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/27/2020 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021747s020lbl.pdf | |
| 06/09/2016 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf | |
| 01/29/2016 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf | |
| 10/17/2014 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf | |
| 10/17/2014 | SUPPL-5 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf | |
| 08/29/2012 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf | |
| 10/07/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf |
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