FDA.reportPublic FDA data

Application 075988

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 5MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0902Prednisolone Sodium PhosphatePrednisolone Sodium PhosphatePharmaceutical Associates, Inc.ANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX, LLC.ANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX LLCANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX LLCANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX LLCANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX, LLC.ANDACurrent
62135-330Prednisolone Sodium Phosphateprednisolone sodium phosphateChartwell RX LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22525ORIG2007-07-06