NDA 213378

ALKERMES INC

FDA Drug Application

Application #213378

Documents

• Letter: 2021-06-01
• Letter: 2021-06-01
• Label: 2021-06-01
• Label: 2021-06-01
• Medication Guide: 2021-06-01
• Review: 2021-06-25
• Review: 2021-06-25

Application Sponsors

NDA 213378

ALKERMES INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET; ORAL	5MG; 10MG	2	LYBALVI	OLANZAPINE; SAMIDORPHAN
002	TABLET; ORAL	10MG; 10MG	2	LYBALVI	OLANZAPINE; SAMIDORPHAN
003	TABLET; ORAL	15MG; 20MG	2	LYBALVI	OLANZAPINE; SAMIDORPHAN
004	TABLET; ORAL	20MG; 10MG	2	LYBALVI	OLANZAPINE; SAMIDORPHAN

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2021-05-28	STANDARD
TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	2	AP	2021-05-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	15

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD
004	Prescription	TBD

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213378
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)