Application 050586

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRED-GGENTAMICIN SULFATE; PREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMICEQ 0.3% BASE;1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-0106PRED-Ggentamicin, prednisolone acetateAllergan, Inc.NDACurrent
0023-0106PRED-Ggentamicin, prednisolone acetateAllergan, Inc.NDACurrent
0023-0106PRED-Ggentamicin, prednisolone acetateAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54559SUPPL2018-06-14
54494SUPPL2018-06-11
47690SUPPL2017-03-24
47624SUPPL2017-03-21
30122SUPPL2006-01-19
7849SUPPL2006-01-19
39009SUPPL2006-01-05
17904SUPPL2006-01-05