Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213378

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LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE)
5MG;EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: OLANZAPINE; SAMIDORPHAN L-MALATE
Proprietary Name: LYBALVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213378
Product Number: 001
Approval Date: May 28, 2021
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE)
10MG;EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: OLANZAPINE; SAMIDORPHAN L-MALATE
Proprietary Name: LYBALVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213378
Product Number: 002
Approval Date: May 28, 2021
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE)
15MG;EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: OLANZAPINE; SAMIDORPHAN L-MALATE
Proprietary Name: LYBALVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213378
Product Number: 003
Approval Date: May 28, 2021
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE)
20MG;EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: OLANZAPINE; SAMIDORPHAN L-MALATE
Proprietary Name: LYBALVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213378
Product Number: 004
Approval Date: May 28, 2021
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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