01 1AMYLYX PHARMACEUTICALS INC.
02 6Acer Therapeutics
03 1Alvogen
04 2ENDO OPERATIONS
05 1Glenmark Pharmaceuticals
06 2Horizon Therapeutics
07 1LUCANE PHARMA SA
08 1Lucane Pharma
09 2MEDUNIK CANADA
10 1NordMedica
11 1Orpharma
12 1Sigmapharm Laboratories, LLC
13 4Swedish Orphan Biovitrum AB
14 2Tobio Novelfarma
01 1Antic-calc Tablet
02 6FOR SUSPENSION;ORAL
03 1GRANULES
04 1Gran
05 4Granules
06 1PELLETS;ORAL
07 1POWDER FOR SUSPENSION
08 3POWDER;ORAL
09 1Sodium Phenylbutyrate 174G 483Mg/G Oral Use
10 1Sodium Phenylbutyrate 266G 940Mg/G Oral Use
11 1Sodium Phenylbutyrate 500Mg 250 Unita' Oral Use
12 4TABLET;ORAL
13 1Blank
01 1DISCN
02 2Lic. No- 24.12.2020/2020-272
03 2Prescription
04 13RX
05 8Blank
01 1ALBRIOZA
02 4Ammonaps
03 2BUPHENYL
04 2HIPER-AMONEMIX
05 6OLPRUVA
06 2PHEBURANE
07 4Pheburane
08 5SODIUM PHENYLBUTYRATE
01 1Australia
02 2Canada
03 3Italy
04 3Norway
05 1Switzerland
06 2Turkey
07 14USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 2GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 3GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 4GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 5GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 6GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OLPRUVA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 6.67GM/PACKET
Packaging :
Approval Date : 2022-12-22
Application Number : 214860
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM PHENYLBUTYRATE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2011-11-18
Application Number : 90910
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM PHENYLBUTYRATE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2022-11-01
Application Number : 216462
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BUPHENYL
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1996-05-13
Application Number : 20572
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BUPHENYL
Dosage Form : POWDER;ORAL
Dosage Strength : 3GM/TEASPOONFUL
Packaging :
Approval Date : 1996-04-30
Application Number : 20573
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PHEBURANE
Dosage Form : PELLETS;ORAL
Dosage Strength : 84GM/BOT
Packaging :
Approval Date : 2022-06-17
Application Number : 216513
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PHEBURANE
Dosage Form : GRANULES
Dosage Strength : 483MG/G
Packaging : 174G
Approval Date :
Application Number : 2436663
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pheburane
Dosage Form : Gran
Dosage Strength : 483mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Pheburane
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM PHENYLBUTYRATE
Dosage Form : POWDER;ORAL
Dosage Strength : 3GM/TEASPOONFUL
Packaging :
Approval Date : 2013-03-22
Application Number : 202819
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Ammonaps
Dosage Form : Sodium Phenylbutyrate 500Mg 250 Unita' Oral Use
Dosage Strength : 250 CPR 500 mg bottle
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ammonaps
Dosage Form : Sodium Phenylbutyrate 266G 940Mg/G Oral Use
Dosage Strength : os granulate for suspension 266 g 940 mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Ammonaps
Dosage Form : Antic-calc Tablet
Dosage Strength : 500 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Ammonaps
Dosage Form : Granules
Dosage Strength : 940 mg/g
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Lic. No- 24.12.2020/2020-272
Registration Country : Turkey
Brand Name : HIPER-AMONEMIX
Dosage Form : Granules
Dosage Strength : 940MG/1G
Packaging : 266 g/ Bottle
Approval Date :
Application Number :
Regulatory Info : Lic. No- 24.12.2020/2020-272
Registration Country : Turkey
Regulatory Info : Lic. No- 24.12.2020/2020-272
Registration Country : Turkey
Brand Name : HIPER-AMONEMIX
Dosage Form : Granules
Dosage Strength : 940MG/1G
Packaging : 266 g/ Bottle
Approval Date :
Application Number :
Regulatory Info : Lic. No- 24.12.2020/2020-272
Registration Country : Turkey
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM PHENYLBUTYRATE
Dosage Form : POWDER;ORAL
Dosage Strength : 3GM/TEASPOONFUL
Packaging :
Approval Date : 2016-06-15
Application Number : 203918
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM PHENYLBUTYRATE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2016-04-15
Application Number : 204395
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Pheburane
Dosage Form : Sodium Phenylbutyrate 174G 483Mg/G Oral Use
Dosage Strength : os grat suspe 174 g 483 mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Pheburane
Dosage Form : Granules
Dosage Strength : 483 mg/g
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ALBRIOZA
Dosage Form : POWDER FOR SUSPENSION
Dosage Strength : 3G/SACHET
Packaging :
Approval Date :
Application Number : 2527707
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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