FDA.reportPublic FDA data

Application 050804

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYLETLOTEPREDNOL ETABONATE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.5%;0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent
24208-358Zyletloteprednol etabonate and tobramycinBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69117SUPPL2021-10-26
69112SUPPL2021-10-26
30592SUPPL2013-02-08
18288SUPPL2013-02-08
30591SUPPL2012-10-04
18287SUPPL2012-10-04
52315SUPPL2010-12-28
52314SUPPL2010-12-28
8324SUPPL2010-06-08
39368SUPPL2010-06-07
42748ORIG2005-06-23
18286ORIG2004-12-30
8323ORIG2004-12-30
64998SUPPL1900-01-01
53039SUPPL1900-01-01
53038SUPPL1900-01-01