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Approved Drug Products containing Letermovir listed in the FDA Orange Book. Original Data : FDA Website

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01 4MERCK SHARP DOHME

02 2MSD

03 2ZYDUS PHARMS USA INC

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PharmaCompass

01

Discovery on Target
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : TABLET;ORAL

Dosage Strength : 240MG

Approval Date : 2017-11-08

Application Number : 209939

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

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Not Confirmed
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : TABLET;ORAL

Dosage Strength : 480MG

Approval Date : 2017-11-08

Application Number : 209939

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Luxepack
Not Confirmed
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Luxepack
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 240MG/12ML (20MG/ML)

Approval Date : 2017-11-08

Application Number : 209940

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

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Not Confirmed
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 480MG/24ML (20MG/ML)

Approval Date : 2017-11-08

Application Number : 209940

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Luxepack
Not Confirmed
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : PELLETS;ORAL

Dosage Strength : 20MG/PACKET

Approval Date : 2024-08-30

Application Number : 219104

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

Luxepack
Not Confirmed
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LETERMOVIR

Brand Name : PREVYMIS

Dosage Form : PELLETS;ORAL

Dosage Strength : 120MG/PACKET

Approval Date : 2024-08-30

Application Number : 219104

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Luxepack
Not Confirmed
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Luxepack
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LETERMOVIR

Brand Name : LETERMOVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 240MG

Approval Date :

Application Number : 216799

RX/OTC/DISCN :

RLD :

TE Code :

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08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

LETERMOVIR

Brand Name : LETERMOVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 480MG

Approval Date :

Application Number : 216799

RX/OTC/DISCN :

RLD :

TE Code :

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