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Approved Drug Products containing SAGE-217 listed in the FDA Orange Book. Original Data : FDA Website

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01

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

FNCE 2024
Not Confirmed
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arrow
FNCE 2024
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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