Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021959

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ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE)
EQ 10MG BASE Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: ORAPRED ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021959
Product Number: 001
Approval Date: Jun 1, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE)
EQ 15MG BASE Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: ORAPRED ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021959
Product Number: 002
Approval Date: Jun 1, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE)
EQ 30MG BASE Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: ORAPRED ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021959
Product Number: 003
Approval Date: Jun 1, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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