Application 050612

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRED-GGENTAMICIN SULFATE; PREDNISOLONE ACETATEOINTMENT;OPHTHALMICEQ 0.3% BASE;0.6%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-0066PRED-Ggentamicin sulfate and prednisolone acetateAllergan, Inc.NDACurrent
0023-0066PRED-Ggentamicin sulfate and prednisolone acetateAllergan, Inc.NDACurrent
0023-0066PRED-Ggentamicin sulfate and prednisolone acetateAllergan, Inc.NDACurrent
0023-0066PRED-Ggentamicin sulfate and prednisolone acetateAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54560SUPPL2018-06-14
54495SUPPL2018-06-11
47691SUPPL2017-03-24
47623SUPPL2017-03-21
30171SUPPL2003-10-28