FDA.reportPublic FDA data

Application 017011

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRED FORTEPREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMIC1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11980-180PRED FORTEprednisolone acetateAllergan, Inc.NDACurrent
11980-180PRED FORTEprednisolone acetateAllergan, Inc.NDACurrent
11980-180PRED FORTEprednisolone acetateAllergan, Inc.NDACurrent
11980-180PRED FORTEprednisolone acetateAllergan, Inc.NDACurrent
11980-180PRED FORTEprednisolone acetateAllergan, Inc.NDACurrent
50090-1912PREDNISOLONE ACETATEprednisolone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5275PREDNISOLONE ACETATEprednisolone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
52959-265PREDNISOLONE ACETATEprednisolone acetateH.J. Harkins Company, Inc.NDA AUTHORIZED GENERICCurrent
60758-119PREDNISOLONE ACETATEprednisolone acetatePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-119PREDNISOLONE ACETATEprednisolone acetatePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
68071-1722PREDNISOLONE ACETATEprednisolone acetateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-2222PREDNISOLONE ACETATEprednisolone acetateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-2222PREDNISOLONE ACETATEprednisolone acetateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
76420-204PREDNISOLONE ACETATEprednisolone acetateAsclemed USA, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54557SUPPL2018-06-14
54492SUPPL2018-06-11
48301SUPPL2017-05-09
48267SUPPL2017-05-08