Application 206302

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BYVALSONNEBIVOLOL HYDROCHLORIDE; VALSARTANTABLET;ORALEQ 5MG BASE;80MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5874Byvalsonnebivolol hydrochloride and valsartanAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74550SUPPL 2023-06-20
74542SUPPL 2023-06-20
45269ORIG2016-09-12
40534ORIG2016-06-06
32793ORIG2016-06-06