01 3AbbVie Inc
02 3ANDA Repository
03 3Alkem Laboratories
04 3Aurobindo Pharma Limited
05 3Chartwell Pharmaceuticals llc
06 5DEVATS INDIA
07 1Jodas Expoim Pvt. Ltd
08 3Lupin Ltd
09 2Nectar Lifesciences
10 4Nobel Ilac Sanayii Ve Ticaret A.S.
11 3Orchid Pharma
12 3Teva Pharmaceutical Industries
13 3Unosource Pharma
14 6World Medicine
15 2XL Laboratories Private Limited
16 2Zim Laboratories
01 4CAPSULE
02 7CAPSULE;ORAL
03 1CAPSULES
04 2Capsule
05 3Dispersible Tablet
06 14FOR SUSPENSION;ORAL
07 3Film Coated Tablet
08 1Hard Gelatin Capsule
09 2ORAL SUSPENSION
10 3Oral Suspension
11 4POWDER FOR ORAL SUSPENSION
12 1Powder For Suspension
13 2Powder for Oral Suspension
14 1TABLET
15 1Taste Masked Granules for Oral Suspension
01 3DISCN
02 8Generic
03 3Generic EU CTD
04 18RX
05 17Blank
01 18CEFDINIR
02 1CEFNAXL
03 1CEFNAXL-125 DT
04 3Klasef
05 1Klasef Plus
06 3OMNICEF
07 3RODINIR
08 19Blank
01 18India
02 10Turkey
03 21USA
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : CEFDINIR
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 250MG/5ML
Packaging :
Approval Date : 2021-02-19
Application Number : 210534
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : ORAL SUSPENSION
Dosage Strength : 125MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : ORAL SUSPENSION
Dosage Strength : 250MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : POWDER FOR ORAL SUSPENSION
Dosage Strength : 125MG/5ML
Packaging : 60 Or 100 Ml/Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : POWDER FOR ORAL SUSPENSION
Dosage Strength : 250MG/5ML
Packaging : 60 Or 100 Ml/Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 300MG
Packaging : 10 Or 20 Capsules
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : India
Brand Name : CEFNAXL
Dosage Form : CAPSULE
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 65330
Regulatory Info : Generic
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : CEFNAXL-125 DT
Dosage Form : TABLET
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
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