FDA.reportPublic FDA data

Application 021879

Type
NDA
Sponsor
AVANIR PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUEDEXTADEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATECAPSULE;ORAL20MG;10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-053Nuedextadextromethorphan hydrobromide and quinidine sulfateOtsuka America Pharmaceutical, IncNDACurrent
64597-301NUEDEXTAdextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDACurrent
64597-301NUEDEXTAdextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDACurrent
64597-301NUEDEXTAdextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDACurrent
64597-301NUEDEXTAdextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68755SUPPL2021-09-24
59035SUPPL2019-06-12
59026SUPPL2019-06-12
57521SUPPL2019-02-13
57396SUPPL2019-02-01
16508SUPPL2015-01-22
6362SUPPL2015-01-21
24223ORIG2011-06-09
21854ORIG2011-06-09
28760ORIG2010-11-03
16507ORIG2010-10-29