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Approved Drug Products containing Deutetrabenazine [USAN:INN] listed in the FDA Orange Book. Original Data : FDA Website

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01 8TEVA

02 6TEVA BRANDED PHARM

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01

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 6MG

Approval Date : 2017-04-03

Application Number : 208082

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 9MG

Approval Date : 2017-04-03

Application Number : 208082

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 12MG

Approval Date : 2017-04-03

Application Number : 208082

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 6MG

Approval Date :

Application Number : 209885

RX/OTC/DISCN :

RLD :

TE Code :

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05

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 9MG

Approval Date :

Application Number : 209885

RX/OTC/DISCN :

RLD :

TE Code :

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06

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO

Dosage Form : TABLET;ORAL

Dosage Strength : 12MG

Approval Date :

Application Number : 209885

RX/OTC/DISCN :

RLD :

TE Code :

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07

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG

Approval Date : 2023-02-17

Application Number : 216354

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 12MG

Approval Date : 2023-02-17

Application Number : 216354

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 24MG

Approval Date : 2023-02-17

Application Number : 216354

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

World Dairy Expo 2024
Not Confirmed
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World Dairy Expo 2024
Not Confirmed

DEUTETRABENAZINE

Brand Name : AUSTEDO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2024-05-29

Application Number : 216354

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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