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01 8Acer Therapeutics

02 1Alvogen

03 2Amgen Inc

04 2Eurocept International Bv

05 7Eurocept Pharmaceuticals

06 1Glenmark Pharmaceuticals

07 10Immedica Pharma

08 1LUCANE PHARMA SA

09 2MEDUNIK CANADA

10 1Medius Ag

11 1Navinta

12 1Orpharma

13 2PH HEALTH

14 1Sigmapharm Laboratories, LLC

15 2Swedish Orphan Biovitrum AB

16 2Tobio Novelfarma

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PharmaCompass

01

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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02

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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03

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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04

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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05

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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06

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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07

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 0.5GM/PACKET

Packaging :

Approval Date : 2025-10-10

Application Number : 214860

Regulatory Info : RX

Registration Country : USA

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08

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 1GM/PACKET

Packaging :

Approval Date : 2025-10-10

Application Number : 214860

Regulatory Info : RX

Registration Country : USA

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09

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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10

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : BUPHENYL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 1996-05-13

Application Number : 20572

Regulatory Info : DISCN

Registration Country : USA

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11

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : BUPHENYL

Dosage Form : POWDER;ORAL

Dosage Strength : 3GM/TEASPOONFUL

Packaging :

Approval Date : 1996-04-30

Application Number : 20573

Regulatory Info : DISCN

Registration Country : USA

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12

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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13

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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14

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : SODIUM PHENYLBUTYRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 220418

Regulatory Info :

Registration Country : USA

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15

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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16

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Sodium 4-Phenylbutyrate

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

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17

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Sodium 4-Phenylbutyrate

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

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18

PH HEALTH

Country
BioProcess International US West
Not Confirmed
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PH HEALTH

Country
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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19

PH HEALTH

Country
BioProcess International US West
Not Confirmed
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PH HEALTH

Country
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BioProcess International US West
Not Confirmed

SODIUM PHENYLBUTYRATE

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

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20

LUCANE PHARMA SA

Country
BioProcess International US West
Not Confirmed
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LUCANE PHARMA SA

Country
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BioProcess International US West
Not Confirmed

Sodium 4-Phenylbutyrate

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

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