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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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