FDA.reportPublic FDA data

Application 021980

Type
NDA
Sponsor
ALCON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUORESCITEFLUORESCEIN SODIUMINJECTABLE;INTRAVENOUSEQ 500MG BASE/5ML (EQ 100MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0092FLUORESCITEfluorescein sodiumAlcon Laboratories, Inc.NDACurrent
0065-0092FLUORESCITEfluorescein sodiumAlcon, Inc.NDACurrent
0065-0092FLUORESCITEfluorescein sodiumAlcon, Inc.NDACurrent
0065-0092FLUORESCITEfluorescein sodiumAlcon, Inc.NDACurrent
0065-0092FLUORESCITEfluorescein sodiumAlcon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69353SUPPL2021-11-18
37989SUPPL2016-02-11
6582SUPPL2016-02-04
42367ORIG2008-02-22
16687ORIG2007-01-23
28971ORIG2006-04-05