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

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01 3ABBVIE

02 3ALKEM LABS LTD

03 3ANDA REPOSITORY

04 3AUROBINDO PHARMA

05 3LUPIN

06 3SANDOZ

07 3TEVA PHARMS

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PharmaCompass

01

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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : OMNICEF

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-12-04

Application Number : 50739

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

02

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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : OMNICEF

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-12-04

Application Number : 50749

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

03

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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : OMNICEF

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2004-07-29

Application Number : 50749

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

04

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Approval Date : 2006-05-31

Application Number : 65259

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Approval Date : 2007-05-07

Application Number : 65259

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 2006-05-19

Application Number : 65264

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

FNCE 2024
Not Confirmed
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08

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Approval Date : 2007-04-06

Application Number : 65337

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Approval Date : 2007-05-04

Application Number : 65332

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Approval Date : 2007-05-04

Application Number : 65332

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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