Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202236
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL 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
05/01/2012 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236_dymista_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2017 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/20/2015 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202236Orig1s008ltr.pdf
10/29/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/02/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/19/2012 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/10/2012 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/20/2015 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf
08/10/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf
08/10/2012 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf
05/01/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s000lbl.pdf

DYMISTA

SPRAY, METERED;NASAL; EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 207712 APOTEX INC
DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 202236 MYLAN SPECIALITY LP

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