FDA.reportPublic FDA data

Application 202236

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYMISTAAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATESPRAY, METERED;NASALEQ 0.125MG BASE/SPRAY;0.05MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda Pharmaceuticals Inc.NDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone PropionateMeda PharmaceuticalsNDACurrent
0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
69621-812Ticalastazelastine hydrochloride and fluticasone propionateShoreline Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80616SUPPL 2024-12-18
80608SUPPL 2024-12-18
67114SUPPL2021-04-19
67100SUPPL2021-04-19
55434SUPPL2018-09-12
55409SUPPL2018-09-07
9994SUPPL2015-02-24
40142SUPPL2015-02-23
51256SUPPL2013-09-06
44849ORIG2013-05-06
43390ORIG2013-05-06
40141SUPPL2012-08-22
32212SUPPL2012-08-17
32211ORIG2012-05-03
40140ORIG2012-05-02
63507ORIG1900-01-01
63506ORIG1900-01-01
54096ORIG1900-01-01
51875SUPPL1900-01-01
51874SUPPL1900-01-01