Application 215712

Type
NDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NASONEX 24HR ALLERGYMOMETASONE FUROATESPRAY, METERED;NASAL0.05MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-1720Nasonexmometasone furoateL. Perrigo CompanyNDACurrent
0113-1720Nasonexmometasone furoateL. Perrigo CompanyNDACurrent
0113-1720Nasonexmometasone furoateL. Perrigo CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78755SUPPL 2024-07-02
78756SUPPL 2024-07-01
74372SUPPL 2023-05-25
74371SUPPL 2023-05-25
73729SUPPL 2023-03-10
73726SUPPL 2023-03-10
73348SUPPL 2023-01-31
73308SUPPL2023-01-30
72135SUPPL2022-09-21
72134SUPPL2022-09-21
72131SUPPL2022-09-21
72122SUPPL2022-09-21
72121SUPPL2022-09-21
72107SUPPL2022-09-19
72049ORIG2022-09-09
71602SUPPL2022-07-19
71601SUPPL2022-07-19
71582SUPPL2022-07-18
71581SUPPL2022-07-18
70554ORIG2022-03-18
70553ORIG2022-03-18