01 6Horizon Therapeutics
02 6ORPHAN EUROPE SARL
03 2Raptor Pharmaceuticals Europe BV
04 2Raptor Solvay *Europe B.V.
05 2Viatris
01 2CAPSULE (DELAYED RELEASE)
02 2CAPSULE, DELAYED RELEASE;ORAL
03 2CAPSULE;ORAL
04 2Capsule, hard
05 2Enteric Capsule
06 2GASTRO-RESISTANT CAPSULE, HARD
07 2GRANULE, DELAYED RELEASE;ORAL
08 2HARD CAPSULES
09 1Mercaptamine 150Mg 100 Unita' Oral Use
10 1Mercaptamine 50Mg 100 Unita' Oral Use
01 2Prescription
02 6RX
03 10Blank
01 4CYSTAGON
02 4Cystagon
03 6PROCYSBI
04 4Procysbi
01 2Canada
02 2Italy
03 4Norway
04 4Sweden
05 6USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROCYSBI
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : EQ 25MG BASE
Packaging :
Approval Date : 2013-04-30
Application Number : 203389
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROCYSBI
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2013-04-30
Application Number : 203389
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROCYSBI
Dosage Form : GRANULE, DELAYED RELEASE;ORAL
Dosage Strength : EQ 75MG BASE/PACKET
Packaging :
Approval Date : 2020-02-14
Application Number : 213491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PROCYSBI
Dosage Form : GRANULE, DELAYED RELEASE;ORAL
Dosage Strength : EQ 300MG BASE/PACKET
Packaging :
Approval Date : 2020-02-14
Application Number : 213491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
CYSTEAMINE (CYSTEAMINE BITARTRATE)
Brand Name : PROCYSBI
Dosage Form : CAPSULE (DELAYED RELEASE)
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number : 2464713
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
CYSTEAMINE (CYSTEAMINE BITARTRATE)
Brand Name : PROCYSBI
Dosage Form : CAPSULE (DELAYED RELEASE)
Dosage Strength : 25MG
Packaging : 50
Approval Date :
Application Number : 2464705
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Brand Name : CYSTAGON
Dosage Form : HARD CAPSULES
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : CYSTAGON
Dosage Form : HARD CAPSULES
Dosage Strength : 150 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Cystagon
Dosage Form : Mercaptamine 50Mg 100 Unita' Oral Use
Dosage Strength : 100 cps 50 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Cystagon
Dosage Form : Mercaptamine 150Mg 100 Unita' Oral Use
Dosage Strength : 100 cps 150 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Cystagon
Dosage Form : Capsule, hard
Dosage Strength : 150 mg
Packaging : Box of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Cystagon
Dosage Form : Capsule, hard
Dosage Strength : 50 mg
Packaging : Box of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : CYSTAGON
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 1994-08-15
Application Number : 20392
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYSTAGON
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 1994-08-15
Application Number : 20392
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Procysbi
Dosage Form : GASTRO-RESISTANT CAPSULE, HARD
Dosage Strength : 75 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Procysbi
Dosage Form : GASTRO-RESISTANT CAPSULE, HARD
Dosage Strength : 25 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Procysbi
Dosage Form : Enteric Capsule
Dosage Strength : 25 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Procysbi
Dosage Form : Enteric Capsule
Dosage Strength : 75 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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