FDA.reportPublic FDA data

Application 021780

Type
NDA
Sponsor
EVUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROMISTNITROGLYCERINAEROSOL, METERED;SUBLINGUAL0.4MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43478-410NitroglycerinnitroglycerinRouses Point PharmNDA AUTHORIZED GENERICCurrent
73262-430NitroMistnitroglycerinEvus Pharmaceuticals, LLCNDACurrent
73262-430NitroMistnitroglycerinEvus Pharmaceuticals, LLCNDACurrent
73262-430NitroMistnitroglycerinEvus Pharmaceuticals, LLCNDACurrent
76299-430NitroMistnitroglycerinMist Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71480SUPPL2022-06-30
71452SUPPL2022-06-27
6176SUPPL2016-06-14
16360SUPPL2016-06-13
37641SUPPL2011-03-11
28590SUPPL2011-03-11
42307ORIG2008-10-28
6175ORIG2006-11-06