FDA.reportPublic FDA data

Application 020583

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTEMAXLOTEPREDNOL ETABONATESUSPENSION/DROPS;OPHTHALMIC0.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-299LOTEMAXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-299LOTEMAXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-299LOTEMAXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-299LOTEMAXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
68682-299Loteprednol Etabonateloteprednol etabonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-299Loteprednol Etabonateloteprednol etabonateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20736SUPPL2015-11-18
20735SUPPL2015-11-18
41446ORIG2002-04-09
34880ORIG1998-03-09
25229ORIG1998-03-09