01 26Novo Nordisk
01 2CAT
02 1Inj L?s
03 1Inj Loose
04 1Inj Solution
05 3Injection fluid, resolution
06 1Injection fluid, resolution in the finished filled pen
07 1Insulin Degludec 300Iu 3Ml 5 Units Parenteral Use
08 2PED
09 2PFP
10 4SOLUTION
11 1SOLUTION FOR INJECTION IN CARTRIDGE
12 2SOLUTION FOR INJECTION IN PRE-FILLED
13 5SOLUTION;SUBCUTANEOUS
01 6Originator
02 1Prescription
03 3Schedule D
04 16Blank
01 1RYZODEG 70/30
02 3Ryzodeg®
03 6TRESIBA
04 7Tresiba
05 2Tresiba 100 U/ml
06 2Tresiba FlexTouch
07 1Tresiba Penfill
08 1XULTOPHY
09 1XULTOPHY 100/3.6
10 2Xultophy
01 4Canada
02 1Italy
03 4Norway
04 6South Africa
05 3Sweden
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 : Sweden
Brand Name : Tresiba
Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED
Dosage Strength : 200 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Tresiba
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 100 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Tresiba
Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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 : Switzerland
Brand Name : Tresiba FlexTouch
Dosage Form : Inj L?s
Dosage Strength : 100U/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Tresiba FlexTouch
Dosage Form : Inj Solution
Dosage Strength : 200U/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Tresiba Penfill
Dosage Form : Inj Loose
Dosage Strength : 100U/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : XULTOPHY
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 1X3ML/3X3ML/5X3ML
Approval Date :
Application Number : 2474875
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML / 5X3ML
Approval Date :
Application Number : 2467879
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 5X3ML
Approval Date :
Application Number : 2467860
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : TRESIBA
Dosage Form : SOLUTION
Dosage Strength : 200UNIT/ML
Packaging : 3ML/ 3X3ML
Approval Date :
Application Number : 2467887
Regulatory Info : Schedule D
Registration Country : Canada
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