Application 207795

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYZULTALATANOPROSTENE BUNODSOLUTION/DROPS;OPHTHALMIC0.024%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-504Vyzultalatanoprostene bunodBausch & Lomb IncorporatedNDACurrent
24208-504Vyzultalatanoprostene bunodBausch & Lomb IncorporatedNDACurrent
24208-504Vyzultalatanoprostene bunodBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54609SUPPL2018-06-19
54597SUPPL2018-06-14
50754ORIG2017-12-18
50465ORIG2017-11-20
50364ORIG2017-11-13