FDA.reportPublic FDA data

Application 020803

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALREXLOTEPREDNOL ETABONATESUSPENSION/DROPS;OPHTHALMIC0.2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-353Alrexloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-353ALREXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-353ALREXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-353ALREXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent
24208-353ALREXloteprednol etabonateBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41713ORIG2003-08-07
25875ORIG1998-03-09
13466ORIG1998-03-09