Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022518
Company: ORGANON LLC
Company: ORGANON LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.1MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | Yes | Yes |
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.2MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | Yes | Yes |
| DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 0.005MG/INH;0.05MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/22/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022518s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022518s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518_dulera_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/12/2019 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022518s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022518Orig1s026ltr.pdf | |
| 03/23/2018 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf | |
| 03/23/2018 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf | |
| 12/20/2017 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s022ltr.pdf | |
| 06/27/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s021ltr.pdf | |
| 05/12/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/2016 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf | |
| 12/24/2015 | SUPPL-18 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022518Orig1s018ltr.pdf |
| 09/18/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2015 | SUPPL-15 | Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022518s015lbl.pdf | |
| 04/17/2014 | SUPPL-14 | Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022518Orig1s014ltr.pdf |
| 08/21/2013 | SUPPL-13 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s013ltr.pdf | |
| 06/10/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s011ltr.pdf | |
| 11/27/2012 | SUPPL-10 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf |
| 01/25/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2013 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s008ltr.pdf | |
| 11/27/2012 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf |
| 11/23/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s006ltr.pdf | |
| 08/21/2012 | SUPPL-5 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s005ltr.pdf | |
| 08/18/2011 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf | |
| 08/18/2011 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/12/2019 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022518s026lbl.pdf | |
| 03/23/2018 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf | |
| 03/23/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf | |
| 03/23/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf | |
| 12/20/2017 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s022lbl.pdf | |
| 06/27/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s021lbl.pdf | |
| 07/12/2016 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf | |
| 04/23/2015 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022518s015lbl.pdf | |
| 08/21/2013 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf | |
| 07/30/2013 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf | |
| 07/30/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf | |
| 01/15/2013 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf | |
| 01/15/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf | |
| 11/23/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf | |
| 08/21/2012 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf | |
| 08/18/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf | |
| 08/18/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf | |
| 06/22/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022518s000lbl.pdf |