Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022518
Company: MERCK SHARP DOHME
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

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