FDA.reportPublic FDA data

Application 203491

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ILEVRONEPAFENACSUSPENSION/DROPS;OPHTHALMIC0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-1750ILEVROnepafenacAlcon Laboratories, Inc.NDACurrent
0065-1750ILEVROnepafenacAlcon Laboratories, Inc.NDACurrent
0065-1750ILEVROnepafenacAlcon Laboratories, Inc.NDACurrent
0065-1750ILEVROnepafenacAlcon Laboratories, Inc.NDACurrent
0078-0743ILEVROnepafenacNovartis Pharmaceuticals CorporationNDACurrent
0078-0743ILEVROnepafenacNovartis Pharmaceuticals CorporationNDACurrent
0078-0743ILEVROnepafenacNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10225SUPPL2014-07-08
43437ORIG2013-04-08
24435ORIG2013-04-08
10224SUPPL2012-12-19
40304SUPPL2012-12-18
10223ORIG2012-10-18
19477ORIG2012-10-17