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Approved Drug Products containing CCDC 710249, HCl salt listed in the FDA Orange Book. Original Data : FDA Website

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01

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

OLANZAPINE; SAMIDORPHAN L-MALATE

Brand Name : LYBALVI

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;EQ 10MG BASE

Approval Date : 2021-05-28

Application Number : 213378

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

OLANZAPINE; SAMIDORPHAN L-MALATE

Brand Name : LYBALVI

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;EQ 10MG BASE

Approval Date : 2021-05-28

Application Number : 213378

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

OLANZAPINE; SAMIDORPHAN L-MALATE

Brand Name : LYBALVI

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG;EQ 10MG BASE

Approval Date : 2021-05-28

Application Number : 213378

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

OLANZAPINE; SAMIDORPHAN L-MALATE

Brand Name : LYBALVI

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG;EQ 10MG BASE

Approval Date : 2021-05-28

Application Number : 213378

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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