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

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01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date : 1999-05-20

Application Number : 21042

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1999-05-20

Application Number : 21042

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2000-02-25

Application Number : 21042

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 12.5MG/5ML

Approval Date : 1999-05-20

Application Number : 21052

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 25MG/5ML

Approval Date : 1999-05-20

Application Number : 21052

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET; ORAL

Dosage Strength : 12.5MG

Approval Date :

Application Number : 21647

RX/OTC/DISCN :

RLD :

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET; ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 21647

RX/OTC/DISCN :

RLD :

TE Code :

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08

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

ROFECOXIB

Brand Name : VIOXX

Dosage Form : TABLET; ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 21647

RX/OTC/DISCN :

RLD :

TE Code :

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