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
BROVANA از شرکت SUNOVION
New Drug Application (NDA): 021912
Company: SUNOVION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROVANA | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2006 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/29/2019 | SUPPL-32 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021912Orig1s032ltr.pdf |
||
| 12/12/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-23 | Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf |
||
| 02/26/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2012 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf |
|
| 08/09/2012 | SUPPL-18 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf |
||
| 09/02/2011 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf |
|
| 02/16/2011 | SUPPL-15 | Labeling, REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf |
||
| 02/01/2011 | SUPPL-12 | REMS-Proposal |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf |
|
| 06/02/2010 | SUPPL-11 | Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf |
||
| 06/22/2010 | SUPPL-8 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/14/2011 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf |
||
| 12/20/2007 | SUPPL-1 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/29/2019 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf | |
| 02/27/2014 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf | |
| 02/27/2014 | SUPPL-23 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf | |
| 07/14/2011 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf | |
| 02/16/2011 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf | |
| 02/16/2011 | SUPPL-15 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf | |
| 06/02/2010 | SUPPL-11 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf | |
| 12/20/2007 | SUPPL-1 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf | |
| 10/06/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf |
BROVANA
SOLUTION;INHALATION; EQ 0.015MG BASE/2ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213762 | AXAR PHARMS INC |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 207306 | CIPLA |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213132 | GLENMARK PHARMS LTD |
| BROVANA | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | Yes | AN | 021912 | SUNOVION |
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