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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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01 4CAPSULE
02 7CAPSULE;ORAL
03 1CAPSULES
04 4Capsule
05 3Dispersible Tablet
06 2Dry Syrup
07 14FOR SUSPENSION;ORAL
08 3Film Coated Tablet
09 2Hard Gelatin Capsule
10 2ORAL SUSPENSION
11 3Oral Suspension
12 4POWDER FOR ORAL SUSPENSION
13 1Powder For Oral Suspension
14 1Powder For Suspension
15 3Powder for Oral Suspension
16 1TABLET
17 1Taste Masked Granules for Oral Suspension
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01 3DISCN
02 2Deregistered
03 8Generic
04 3Generic EU CTD
05 18RX
06 22Blank
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01 18CEFDINIR
02 1CEFNAXL
03 1CEFNAXL-125 DT
04 3Cefdinir
05 3Klasef
06 1Klasef Plus
07 3OMNICEF
08 2Omnicef
09 3RODINIR
10 2Torbener
11 19Blank
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01 2Egypt
02 21India
03 2Sweden
04 10Turkey
05 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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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