Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216655

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OPIPZA (ARIPIPRAZOLE)
2MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: OPIPZA
Dosage Form; Route of Administration: FILM; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216655
Product Number: 001
Approval Date: Jul 22, 2024
Applicant Holder Full Name: XIAMEN LP PHARMACUETICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OPIPZA (ARIPIPRAZOLE)
5MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: OPIPZA
Dosage Form; Route of Administration: FILM; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216655
Product Number: 002
Approval Date: Jul 22, 2024
Applicant Holder Full Name: XIAMEN LP PHARMACUETICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OPIPZA (ARIPIPRAZOLE)
10MG
Marketing Status: Prescription

Active Ingredient: ARIPIPRAZOLE
Proprietary Name: OPIPZA
Dosage Form; Route of Administration: FILM; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216655
Product Number: 003
Approval Date: Jul 22, 2024
Applicant Holder Full Name: XIAMEN LP PHARMACUETICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information