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01 7ORION PHARMA

02 1AJANTA PHARMA LTD

03 1ALEMBIC

04 1AUROBINDO PHARMA LTD

05 1MACLEODS PHARMS LTD

06 7NORVIUM BIOSCIENCE

07 6RISING

08 3SUN PHARM

09 1SUNSHINE

10 1WOCKHARDT BIO AG

11 6WOCKHARDT LTD

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PharmaCompass

01

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BioFlorida Conference
Not Confirmed

ENTACAPONE

Brand Name : COMTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 1999-10-19

Application Number : 20796

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

02

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 50

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;200MG;50MG

Approval Date : 2003-06-11

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

03

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 100

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;200MG;100MG

Approval Date : 2003-06-11

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

04

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 150

Dosage Form : TABLET;ORAL

Dosage Strength : 37.5MG;200MG;150MG

Approval Date : 2003-06-11

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

05

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 200

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG;200MG;200MG

Approval Date : 2007-08-02

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

06

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 75

Dosage Form : TABLET;ORAL

Dosage Strength : 18.75MG;200MG;75MG

Approval Date : 2008-08-29

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

07

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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 125

Dosage Form : TABLET;ORAL

Dosage Strength : 31.25MG;200MG;125MG

Approval Date : 2008-08-29

Application Number : 21485

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Fermion Orion Company Banner

08

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : CARBIDOPA, LEVODOPA AND ENTACAPONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;200MG;100MG

Approval Date : 2012-05-10

Application Number : 79085

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : CARBIDOPA, LEVODOPA AND ENTACAPONE

Dosage Form : TABLET;ORAL

Dosage Strength : 37.5MG;200MG;150MG

Approval Date : 2012-05-10

Application Number : 79085

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

ENTACAPONE

Brand Name : ENTACAPONE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2012-08-16

Application Number : 78941

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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