An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 202236
Company: MYLAN SPECIALITY LP

Summary Review

Products on NDA 202236

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DYMISTA	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202236

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
04/16/2021	SUPPL-13	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202236s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202236Orig1s013ltr.pdf
09/06/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202236s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202236Orig1s010ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 202236

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2021	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202236s013lbl.pdf
04/16/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202236s013lbl.pdf
09/06/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202236s010lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf
08/10/2012	SUPPL-1	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 202236

DYMISTA

SPRAY, METERED;NASAL; 0.137MG/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	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	207712	APOTEX
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	208111	PADAGIS ISRAEL
DYMISTA	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	202236	MYLAN SPECIALITY LP

Top