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

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01 3SI PHARMS

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PharmaCompass

01

SI PHARMS

Country
AAPS 2024
Not Confirmed
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SI PHARMS

Country
arrow
AAPS 2024
Not Confirmed

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 1995-12-20

Application Number : 50685

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

SI PHARMS

Country
AAPS 2024
Not Confirmed
arrow

SI PHARMS

Country
arrow
AAPS 2024
Not Confirmed

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-12-20

Application Number : 50686

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

SI PHARMS

Country
AAPS 2024
Not Confirmed
arrow

SI PHARMS

Country
arrow
AAPS 2024
Not Confirmed

CEFTIBUTEN DIHYDRATE

Brand Name : CEDAX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-12-20

Application Number : 50686

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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