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Approved Drug Products containing rotigotine transdermal patch listed in the FDA Orange Book. Original Data : FDA Website

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01

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 2MG/24HR

Approval Date : 2007-05-09

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 4MG/24HR

Approval Date : 2007-05-09

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 6MG/24HR

Approval Date : 2007-05-09

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 1MG/24HR

Approval Date : 2012-04-02

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 3MG/24HR

Approval Date : 2012-04-02

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

34th IFSCC
Not Confirmed
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34th IFSCC
Not Confirmed

ROTIGOTINE

Brand Name : NEUPRO

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 8MG/24HR

Approval Date : 2012-04-02

Application Number : 21829

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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