Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021077
Company: GLAXO GRP LTD
Company: GLAXO GRP LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVAIR DISKUS 100/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | Yes | Yes |
| ADVAIR DISKUS 250/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | Yes | Yes |
| ADVAIR DISKUS 500/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/24/2000 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_AdvairDiskus.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021077s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021077Orig1s061ltr.pdf | |
| 02/28/2017 | SUPPL-58 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s058ltr.pdf | |
| 12/20/2017 | SUPPL-57 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s056s057ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021077Orig1s057.pdf | |
| 12/20/2017 | SUPPL-56 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s056s057ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021077Orig1s056.pdf | |
| 04/29/2016 | SUPPL-54 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021077Orig1s054ltr.pdf | |
| 11/13/2014 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s053ltr.pdf | |
| 06/17/2014 | SUPPL-52 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s052.pdf |
| 04/14/2014 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s051.pdf | |
| 06/19/2013 | SUPPL-50 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021077Orig1s050.pdf |
| 08/09/2012 | SUPPL-49 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf |
| 08/09/2012 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 06/27/2011 | SUPPL-47 | REMS-Assessment, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf |
| 05/10/2011 | SUPPL-46 | REMS-Assessment, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf |
| 06/25/2010 | SUPPL-42 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf | |
| 01/04/2011 | SUPPL-41 | REMS-Assessment, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s041ltr.pdf |
| 03/31/2009 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021077s036ltr.pdf |
| 04/30/2008 | SUPPL-29 | Efficacy-New Dosing Regimen, REMS-Proposal |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021077se2-029_SUMR.pdf | |
| 03/02/2006 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf | |
| 02/23/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf | |
| 09/27/2006 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s026LTR.pdf | |
| 09/28/2004 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf | |
| 08/11/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077slr019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_s019_ADVAIR DISKUS.pdf | |
| 04/21/2004 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077se5-017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021077Orig1s017.pdf | |
| 05/17/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21077slr008ltr.pdf |
| 10/16/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/2003 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077se1-003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077Orig1S003.pdf | |
| 12/22/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021077s061lbl.pdf | |
| 12/20/2017 | SUPPL-57 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf | |
| 12/20/2017 | SUPPL-56 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf | |
| 02/28/2017 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf | |
| 02/28/2017 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf | |
| 04/29/2016 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf | |
| 11/13/2014 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf | |
| 04/14/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf | |
| 04/14/2014 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf | |
| 06/25/2010 | SUPPL-42 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf | |
| 04/30/2008 | SUPPL-29 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf | |
| 04/30/2008 | SUPPL-29 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf | |
| 02/23/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf | |
| 09/27/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf | |
| 03/02/2006 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf | |
| 09/28/2004 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf | |
| 04/21/2004 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf | |
| 11/17/2003 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf | |
| 08/11/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf |
ADVAIR DISKUS 100/50
POWDER;INHALATION; 0.1MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADVAIR DISKUS 100/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
| WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |
ADVAIR DISKUS 250/50
POWDER;INHALATION; 0.25MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADVAIR DISKUS 250/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
| WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |
ADVAIR DISKUS 500/50
POWDER;INHALATION; 0.5MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADVAIR DISKUS 500/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
| WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |