Application 017100

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRED MILDPREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMIC0.12%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11980-174PRED MILDprednisolone acetateAllergan, Inc.NDACurrent
11980-174PRED MILDprednisolone acetateAllergan, Inc.NDACurrent
11980-174PRED MILDprednisolone acetateAllergan, Inc.NDACurrent
11980-174PRED MILDprednisolone acetateAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84332SUPPL 2025-11-28
84323SUPPL 2025-11-28
72865SUPPL2022-12-12
72861SUPPL2022-12-12
54548SUPPL2018-06-14
54490SUPPL2018-06-11
48298SUPPL2017-05-09
48268SUPPL2017-05-08