FDA.reportPublic FDA data

Application 022186

Type
NDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AK-FLUOR 10%FLUORESCEIN SODIUMINJECTABLE;INTRAVENOUSEQ 500MG BASE/5ML (EQ 100MG BASE/ML)YesNo
002AK-FLUOR 25%FLUORESCEIN SODIUMINJECTABLE;INTRAVENOUSEQ 500MG BASE/2ML (EQ 250MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-250AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
17478-253AK-FLUORfluorescein sodiumAkornNDACurrent
50090-4535AK-FLUORfluorescein sodiumA-S Medication SolutionsNDACurrent
50090-4535AK-FLUORfluorescein sodiumA-S Medication SolutionsNDACurrent
51662-1533FLUORESCEINFLUORESCEINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1533FLUORESCEINFLUORESCEINHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85529SUPPL 2026-03-25
85528SUPPL 2026-03-25
81416SUPPL 2025-03-04
81415SUPPL 2025-03-04
44696ORIG2009-08-26
42440ORIG2009-08-26
29372ORIG2008-08-13