Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203559

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PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE SODIUM PHOSPHATE)
EQ 10MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 10MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203559
Product Number: 001
Approval Date: Dec 20, 2016
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE SODIUM PHOSPHATE)
EQ 15MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 15MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203559
Product Number: 003
Approval Date: Feb 6, 2023
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE SODIUM PHOSPHATE)
EQ 20MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 20MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203559
Product Number: 002
Approval Date: Dec 20, 2016
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE SODIUM PHOSPHATE)
EQ 25MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Proprietary Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 25MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203559
Product Number: 004
Approval Date: Feb 6, 2023
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information