FDA.reportPublic FDA data

Application 211039

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEBENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUMSOLUTION/DROPS;OPHTHALMIC0.4%;0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-734Fluorescein Sodium and Benoxinate HydrochlorideFluorescein Sodium and Benoxinate HydrochlorideBausch & Lomb IncorporatedNDACurrent
68682-732Fluorescein Sodium and Benoxinate HydrochlorideFluorescein Sodium and Benoxinate HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65065ORIG2020-10-29
62104ORIG2020-05-11
62094ORIG2020-03-09