FDA.reportPublic FDA data

Application 022211

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIRGANGANCICLOVIRGEL;OPHTHALMIC0.15%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-535ZIRGANganciclovirBausch & Lomb IncorporatedNDACurrent
24208-535ZIRGANganciclovirBausch & Lomb IncorporatedNDACurrent
24208-535ZIRGANganciclovirBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84799SUPPL 2026-01-21
84789SUPPL 2026-01-21
24261ORIG2010-01-05
21959ORIG2010-01-05
17092ORIG2009-09-21
7055ORIG2009-09-21