FDA.reportPublic FDA data

Application 019157

Type
NDA
Sponsor
SETON PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEDIAPREDPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 5MG BASE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0902Prednisolone Sodium PhosphatePrednisolone Sodium PhosphatePharmaceutical Associates, Inc.NDACurrent
13925-166Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateSeton Pharmaceuticals, LLCNDACurrent
13925-166Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateSeton Pharmaceuticals, LLCNDACurrent
68791-104PEDIAPREDPrednisolone Sodium PhosphateRoyal PharmaceuticalsNDACurrent
68791-104PEDIAPREDPrednisolone Sodium PhosphateRoyal PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78717SUPPL 2024-06-07
78682SUPPL 2024-06-06
52514SUPPL2018-02-08
52431SUPPL2018-02-06
33702SUPPL2013-10-17
1245SUPPL2013-10-10
40876ORIG2007-04-11
20211SUPPL2006-05-08
11443SUPPL2004-12-08
1244SUPPL2004-12-08
40877SUPPL2003-09-11
16207SUPPL1998-12-17
1243SUPPL1998-12-17
1242SUPPL1998-12-17
1241SUPPL1998-12-17