01 2Clinigen Group
02 1Dipharma
03 1Eurocept Pharmaceuticals
04 1Navinta
05 1Novitium Pharma LLC
06 6ORPHAN EUROPE SARL
07 3Recordati
08 1Recordati Rare Diseases
09 2Waymade
01 1Carglumic Acid 200Mg 5 Units' Oral Use
02 1Carglumic Acid 200Mg 60 Units Oral Use
03 1DISPERSIBLE TABLET
04 2DSP
05 3Dispergerbar Antic-Calc tablet
06 2Dispersible Tablet
07 1Dispersible Tablet Oral Use Blister
08 2Dispersible Tablets
09 1TABLET FOR SUSPENSION
10 3TABLET, FOR SUSPENSION;ORAL
11 1Tablet
01 2Originator
02 3RX
03 13Blank
01 6CARBAGLU
02 2CARGLUMIC ACID
03 6Carbaglu
04 1Diglumic
05 1UCEDANE
06 1WAYMADE CARGLUMIC ACID
07 1WAYMADE CARGLUMIC ACID*
01 1Canada
02 8Italy
03 3Norway
04 2South Africa
05 1Sweden
06 3USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : CARBAGLU
Dosage Form : DSP
Dosage Strength : 200mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : CARBAGLU
Dosage Form : DSP
Dosage Strength : 200mg
Packaging : 5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Italy
Brand Name : Diglumic
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : UCEDANE
Dosage Form : Dispersible Tablet Oral Use Blister
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : RX
Registration Country : USA
Brand Name : CARGLUMIC ACID
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2022-06-22
Application Number : 213395
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CARGLUMIC ACID
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2021-10-13
Application Number : 213729
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Carbaglu
Dosage Form : DISPERSIBLE TABLET
Dosage Strength : 200 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Carbaglu
Dosage Form : Carglumic Acid 200Mg 60 Units Oral Use
Dosage Strength : 60 cpr dispers 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Carbaglu
Dosage Form : Carglumic Acid 200Mg 5 Units' Oral Use
Dosage Strength : 5 cpr dispers 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Carbaglu
Dosage Form : Dispergerbar Antic-Calc tablet
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : CARBAGLU
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2010-03-18
Application Number : 22562
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : CARBAGLU
Dosage Form : Dispersible Tablet
Dosage Strength : 200 mg
Packaging : 5 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : CARBAGLU
Dosage Form : Dispersible Tablet
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Canada
Brand Name : CARBAGLU
Dosage Form : TABLET FOR SUSPENSION
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 2439360
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Italy
Brand Name : WAYMADE CARGLUMIC ACID
Dosage Form : Dispersible Tablets
Dosage Strength : 200 mg
Packaging : 5 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : WAYMADE CARGLUMIC ACID*
Dosage Form : Dispersible Tablets
Dosage Strength : 200 mg
Packaging : 60 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
