01 27Novo Nordisk
01 2CAT
02 3Injection fluid, resolution
03 1Injection fluid, resolution in the finished filled pen
04 1Insulin Degludec 300Iu 3Ml 5 Units Parenteral Use
05 2PED
06 2PFP
07 4SOLUTION
08 5SOLUTION;SUBCUTANEOUS
09 7Solution For Injection
01 3Allowed
02 4Approved
03 6Originator
04 14Blank
01 1RYZODEG 70/30
02 3Ryzodeg®
03 6TRESIBA
04 4Tresiba
05 2Tresiba 100 U/ml
06 2Tresiba FlexTouch Eml
07 1Tresiba Flexpen
08 2Tresiba Flextouch
09 2Tresiba Penfill
10 1XULTOPHY
11 1XULTOPHY 100/3.6
12 2Xultophy
01 4Canada
02 1Italy
03 4Norway
04 6South Africa
05 4Sweden
06 3Switzerland
07 5USA
Regulatory Info :
Registration Country : USA
INSULIN ASPART; INSULIN DEGLUDEC
Brand Name : RYZODEG 70/30
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203313
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 600 UNITS/3ML (200 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TRESIBA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 1000 UNITS/10ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 203314
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : XULTOPHY 100/3.6
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)
Packaging :
Approval Date :
Application Number : 208583
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Tresiba
Dosage Form : Insulin Degludec 300Iu 3Ml 5 Units Parenteral Use
Dosage Strength : FLEXTOUCH SC 5 pens preriemp 3 ml 100 IU/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 E/ml
Packaging : Finish filled pen, flex touch
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 E/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tresiba
Dosage Form : Injection fluid, resolution
Dosage Strength : 200 E/ml
Packaging : Finish filled pen, flex touch
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xultophy
Dosage Form : Injection fluid, resolution in the finished filled pen
Dosage Strength : 100 E/ml/3.6 mg/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 5X3ML
Approval Date :
Application Number : 2467860
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML / 5X3ML
Approval Date :
Application Number : 2467879
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 200UNIT/ML
Packaging : 3ML/ 3X3ML
Approval Date :
Application Number : 2467887
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XULTOPHY
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 1X3ML/3X3ML/5X3ML
Approval Date :
Application Number : 2474875
Regulatory Info :
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Tresiba 100 U/ml
Dosage Form : CAT
Dosage Strength : 100U/ml
Packaging : 3X5U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ryzodeg®
Dosage Form : PFP
Dosage Strength : 70U/ml
Packaging : 3X1U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ryzodeg®
Dosage Form : PFP
Dosage Strength : 70U/ml
Packaging : 3X5U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ryzodeg®
Dosage Form : CAT
Dosage Strength : 70U/ml
Packaging : 3X5U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Tresiba 100 U/ml
Dosage Form : PED
Dosage Strength : 100U/ml
Packaging : 3X5U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Xultophy
Dosage Form : PED
Dosage Strength : 100U/ml
Packaging : 3X3U/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
