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
ADVAIR HFA از شرکت GLAXO GRP LTD
New Drug Application (NDA): 021254
Company: GLAXO GRP LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription |
None |
Yes | Yes |
| ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription |
None |
Yes | Yes |
| ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, 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 |
|---|---|---|---|---|---|---|---|
| 06/08/2006 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021254s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021254Orig1s028ltr.pdf |
||
| 12/20/2017 | SUPPL-27 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s027ltr.pdf |
||
| 02/28/2017 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s026ltr.pdf |
||
| 12/10/2014 | SUPPL-24 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s024ltr.pdf |
||
| 11/13/2014 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s023ltr.pdf |
||
| 06/17/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2012 | SUPPL-19 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf |
|
| 08/09/2012 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/27/2011 | SUPPL-16 | REMS-Modified, REMS-Assessment |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf |
|
| 05/10/2011 | SUPPL-15 | REMS-Modified, REMS-Assessment |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf |
||
| 06/25/2010 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf |
||
| 01/04/2011 | SUPPL-12 | REMS-Assessment, REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021254s012ltr.pdf |
|
| 12/19/2012 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021254Orig1s009ltr.pdf |
||
| 09/15/2009 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021254s007ltr.pdf |
||
| 07/31/2008 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Proposal |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s004ltr.pdf |
|
| 03/20/2008 | SUPPL-3 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021254s028lbl.pdf | |
| 12/20/2017 | SUPPL-27 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf | |
| 02/28/2017 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf | |
| 02/28/2017 | SUPPL-26 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf | |
| 12/10/2014 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf | |
| 11/13/2014 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf | |
| 12/19/2012 | SUPPL-9 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf | |
| 05/10/2011 | SUPPL-15 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf | |
| 05/10/2011 | SUPPL-15 |
REMS-Assessment |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf | |
| 06/25/2010 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf | |
| 06/25/2010 | SUPPL-13 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf | |
| 09/15/2009 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf | |
| 03/20/2008 | SUPPL-3 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf | |
| 06/08/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf |
نظرات کاربران