Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202691

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METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202691
Product Number: 001
Approval Date: Feb 16, 2016
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
EQ 1GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202691
Product Number: 002
Approval Date: Feb 16, 2016
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information