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

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06 3CHARTWELL RX

07 2FOSUN PHARMA

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PharmaCompass

01

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CEFUROXIME AXETIL

Brand Name : CEFTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-12-28

Application Number : 50605

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

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CEFUROXIME AXETIL

Brand Name : CEFTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-12-28

Application Number : 50605

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

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CEFUROXIME AXETIL

Brand Name : CEFTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-12-28

Application Number : 50605

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

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CEFUROXIME AXETIL

Brand Name : CEFTIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 125MG BASE/5ML

Approval Date : 1994-06-30

Application Number : 50672

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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CEFUROXIME AXETIL

Brand Name : CEFTIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 250MG BASE/5ML

Approval Date : 1997-04-29

Application Number : 50672

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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CEFUROXIME

Brand Name : CEFUROXIME

Dosage Form : Injectable; Injection

Dosage Strength : 1.5G/20ML

Approval Date :

Application Number : 65048

RX/OTC/DISCN :

RLD :

TE Code :

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CEFUROXIME

Brand Name : CEFUROXIME

Dosage Form : Injectable; Injection

Dosage Strength : 1.5G/100ML

Approval Date :

Application Number : 65048

RX/OTC/DISCN :

RLD :

TE Code :

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08

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CEFUROXIME AXETIL

Brand Name : CEFUROXIME AXETIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 2002-02-15

Application Number : 65043

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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CEFUROXIME AXETIL

Brand Name : CEFUROXIME AXETIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Approval Date : 2002-02-15

Application Number : 65043

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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CEFUROXIME AXETIL

Brand Name : CEFUROXIME AXETIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 125MG BASE

Approval Date : 2002-02-15

Application Number : 65043

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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