Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211448

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MEZOFY (ARIPIPRAZOLE)
5MG
Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: MEZOFY
Dosage Form; Route of Administration: FILM; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211448
Product Number: 001
Approval Date: Apr 15, 2025
Applicant Holder Full Name: CMG PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

MEZOFY (ARIPIPRAZOLE)
10MG
Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: MEZOFY
Dosage Form; Route of Administration: FILM; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211448
Product Number: 002
Approval Date: Apr 15, 2025
Applicant Holder Full Name: CMG PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

MEZOFY (ARIPIPRAZOLE)
15MG
Marketing Status: Discontinued

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: MEZOFY
Dosage Form; Route of Administration: FILM; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211448
Product Number: 003
Approval Date: Apr 15, 2025
Applicant Holder Full Name: CMG PHARMACEUTICAL CO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information