FDA.reportPublic FDA data

Application 020706

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMADINEEMEDASTINE DIFUMARATESOLUTION/DROPS;OPHTHALMIC0.05%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0325EMADINEEMEDASTINE DIFUMARATEAlcon Laboratories, Inc.NDACurrent
0065-0325EMADINEEMEDASTINE DIFUMARATEAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20863ORIG2010-05-25
3143SUPPL2003-06-08
13254SUPPL2003-05-29