FDA.reportPublic FDA data

Application 017469

Type
NDA
Sponsor
NOVARTIS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0638OMNIPREDprednisolone acetateAlcon Laboratories, Inc.NDACurrent
0065-0638OMNIPREDprednisolone acetateAlcon Laboratories, Inc.NDACurrent
0065-0638OMNIPREDprednisolone acetateAlcon Laboratories, Inc.NDACurrent
0065-0638OMNIPREDprednisolone acetateAlcon Laboratories, Inc.NDACurrent
50090-0559Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0559Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0559Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0561Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0561Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0561Prednisolone AcetatePrednisolone AcetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
61314-637Prednisolone AcetatePrednisolone AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
61314-637Prednisolone AcetatePrednisolone AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
61314-637Prednisolone AcetatePrednisolone AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
61314-637Prednisolone AcetatePrednisolone AcetateSandoz Inc.NDA AUTHORIZED GENERICCurrent
72189-055PREDNISOLONE ACETATEPREDNISOLONE ACETATEDIRECT RXNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80637SUPPL 2025-02-11
80641SUPPL 2024-12-19
70492SUPPL2022-03-11
70406SUPPL2022-03-07
10998SUPPL2007-10-15
596SUPPL2007-10-15
13148SUPPL2006-05-18
33278SUPPL2006-05-16
33277SUPPL2006-05-16
13147SUPPL2003-07-31
33276SUPPL2003-05-28