FDA.reportPublic FDA data

Application 021959

Type
NDA
Sponsor
CONCORDIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORAPRED ODTPREDNISOLONE SODIUM PHOSPHATETABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASEYesNo
002ORAPRED ODTPREDNISOLONE SODIUM PHOSPHATETABLET, ORALLY DISINTEGRATING;ORALEQ 15MG BASEYesNo
003ORAPRED ODTPREDNISOLONE SODIUM PHOSPHATETABLET, ORALLY DISINTEGRATING;ORALEQ 30MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-700Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-700Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-700Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-700Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-700Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-701Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-701Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-701Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-701Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-701Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-702Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-702Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-702Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-702Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
59212-702Orapredprednisolone sodium phosphateConcordia Pharmaceuticals Inc.NDACurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-844Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-845Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-846Prednisolone Sodium Phosphateprednisolone sodium phosphatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78719SUPPL 2024-06-07
78685SUPPL 2024-06-06
62098SUPPL2020-03-10
62088SUPPL2020-03-09
16645SUPPL2010-07-31
28927SUPPL2010-07-30
16644SUPPL2009-05-11
6546SUPPL2009-05-05
42359ORIG2008-07-08
37957ORIG2006-06-02