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01 3AbbVie Inc

02 3ANDA Repository

03 3Alkem Laboratories

04 3Associated Biotech

05 2Astellas Pharma

06 3Aurobindo Pharma Limited

07 3Chartwell Pharmaceuticals llc

08 5DEVATS INDIA

09 1Jodas Expoim Pvt. Ltd

10 3Lupin Ltd

11 2Nectar Lifesciences

12 4Nobel Ilac Sanayii Ve Ticaret A.S.

13 3Orchid Pharma

14 3Teva Pharmaceutical Industries

15 3Unosource Pharma

16 2Utopia

17 6World Medicine

18 2XL Laboratories Private Limited

19 2Zim Laboratories

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PharmaCompass

01

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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-12-04

Application Number : 50739

Regulatory Info : DISCN

Registration Country : USA

Abbvie Company Banner

02

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Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-12-04

Application Number : 50749

Regulatory Info : DISCN

Registration Country : USA

Abbvie Company Banner

03

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Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2004-07-29

Application Number : 50749

Regulatory Info : DISCN

Registration Country : USA

Abbvie Company Banner

04

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2021-02-19

Application Number : 210220

Regulatory Info : RX

Registration Country : USA

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05

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2021-02-19

Application Number : 210534

Regulatory Info : RX

Registration Country : USA

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06

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2007-07-18

Application Number : 65418

Regulatory Info : RX

Registration Country : USA

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07

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2007-07-18

Application Number : 65429

Regulatory Info : RX

Registration Country : USA

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08

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Packaging :

Approval Date : 2007-07-18

Application Number : 65429

Regulatory Info : RX

Registration Country : USA

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09

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2008-01-07

Application Number : 65434

Regulatory Info : RX

Registration Country : USA

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10

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2007-12-14

Application Number : 65473

Regulatory Info : RX

Registration Country : USA

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11

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Packaging :

Approval Date : 2007-12-14

Application Number : 65473

Regulatory Info : RX

Registration Country : USA

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12

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2007-04-06

Application Number : 65330

Regulatory Info : RX

Registration Country : USA

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13

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2007-04-06

Application Number : 65337

Regulatory Info : RX

Registration Country : USA

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14

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Packaging :

Approval Date : 2007-04-06

Application Number : 65337

Regulatory Info : RX

Registration Country : USA

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15

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2006-05-31

Application Number : 65259

Regulatory Info : RX

Registration Country : USA

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16

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Packaging :

Approval Date : 2007-05-07

Application Number : 65259

Regulatory Info : RX

Registration Country : USA

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17

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2006-05-19

Application Number : 65264

Regulatory Info : RX

Registration Country : USA

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18

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Packaging :

Approval Date : 2007-05-04

Application Number : 65332

Regulatory Info : RX

Registration Country : USA

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19

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Packaging :

Approval Date : 2007-05-04

Application Number : 65332

Regulatory Info : RX

Registration Country : USA

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20

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

CEFDINIR

Brand Name : CEFDINIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2007-05-09

Application Number : 65368

Regulatory Info : RX

Registration Country : USA

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