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

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01 2AZURITY

02 2GLENMARK PHARMS LTD

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01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

GABAPENTIN ENACARBIL

Brand Name : HORIZANT

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Approval Date : 2011-04-06

Application Number : 22399

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

GABAPENTIN ENACARBIL

Brand Name : HORIZANT

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date : 2011-12-13

Application Number : 22399

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

GABAPENTIN ENCARBIL

Brand Name : GABAPENTIN ENCARBIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date :

Application Number : 213501

RX/OTC/DISCN :

RLD :

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

GABAPENTIN ENCARBIL

Brand Name : GABAPENTIN ENCARBIL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Approval Date :

Application Number : 213501

RX/OTC/DISCN :

RLD :

TE Code :

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