Application 021737

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETISERTFLUOCINOLONE ACETONIDEIMPLANT;INTRAVITREAL0.59MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-416RetisertFluocinolone AcetonideBausch & Lomb IncorporatedNDACurrent
24208-416RetisertFluocinolone AcetonideBausch & Lomb IncorporatedNDACurrent
24208-416RetisertFluocinolone AcetonideBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81889SUPPL 2025-04-08
81829SUPPL 2025-04-07
16284SUPPL2011-06-07
6089SUPPL2011-06-06
6088SUPPL2010-12-03
28496SUPPL2008-08-07
28495SUPPL2007-11-08
37558SUPPL2007-11-07
42291ORIG2007-01-22
16283ORIG2005-04-12
6087ORIG2005-04-12