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Drugs@FDA: FDA-Approved Drugs

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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-Package Insert, Labeling-Patient 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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202236s013lbl.pdf
04/16/2021	SUPPL-13	Labeling-Patient 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

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