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01 6Acer Therapeutics

02 1Alvogen

03 2Amgen Inc

04 2Endo International

05 1Glenmark Pharmaceuticals

06 1LUCANE PHARMA SA

07 1Lucane Pharma

08 2MEDUNIK CANADA

09 1NordMedica

10 1Orpharma

11 1Sigmapharm Laboratories, LLC

12 4Swedish Orphan Biovitrum AB

13 2Tobio Novelfarma

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PharmaCompass

01

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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08

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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 : RX

Registration Country : USA

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09

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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 : RX

Registration Country : USA

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10

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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11

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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12

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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15

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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16

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
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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17

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
Not Confirmed

Sodium 4-Phenylbutyrate

Brand Name : Ammonaps

Dosage Form : Antic-calc Tablet

Dosage Strength : 500 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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18

BIO Asia-Taiwan
Not Confirmed
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BIO Asia-Taiwan
Not Confirmed

Sodium 4-Phenylbutyrate

Brand Name : Ammonaps

Dosage Form : Granules

Dosage Strength : 940 mg/g

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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19

LUCANE PHARMA SA

Country
BIO Asia-Taiwan
Not Confirmed
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LUCANE PHARMA SA

Country
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BIO Asia-Taiwan
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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20

Lucane Pharma

Country
BIO Asia-Taiwan
Not Confirmed
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Lucane Pharma

Country
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BIO Asia-Taiwan
Not Confirmed

Sodium 4-Phenylbutyrate

Brand Name : Pheburane

Dosage Form : Granules

Dosage Strength : 483 mg/g

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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