FDA.reportPublic FDA data

Application 021862

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEVANACNEPAFENACSUSPENSION/DROPS;OPHTHALMIC0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0078-0778NEVANACnepafenacNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65162SUPPL2020-11-09
65158SUPPL2020-11-05
50832SUPPL2017-12-22
50781SUPPL2017-12-20
6329SUPPL2011-07-05
16477SUPPL2011-06-27
37780SUPPL2008-06-12
42331ORIG2005-10-06
16476ORIG2005-08-23
6328ORIG2005-08-23