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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214297

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METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
80MG/ML
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE ACETATE
Proprietary Name: METHYLPREDNISOLONE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214297
Product Number: 002
Approval Date: Jan 21, 2022
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
40MG/ML
Marketing Status: Discontinued
Active Ingredient: METHYLPREDNISOLONE ACETATE
Proprietary Name: METHYLPREDNISOLONE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214297
Product Number: 001
Approval Date: Jan 21, 2022
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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