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01 1Accord healthcare

02 1Ajanta Pharma Limited

03 1Amneal Pharmaceuticals

04 1Aristo Pharma GmbH

05 1Ascend Gmbh

06 4Avadel Pharmaceuticals

07 2C.T. LAB.FARMACEUTICO Srl

08 9Farmak JSC

09 1Hikma Pharmaceuticals

10 4Jazz Pharmaceuticals

11 4Kalcex

12 1LABORATORIO REIG JOFRE SA

13 1LABORATORIOS NORMON SA

14 1Pharmathen SA

15 1Reig Jofre

16 1Sun Pharmaceutical Industries Limited

17 5UCB Pharma S.A

18 1Zentiva

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PharmaCompass

01

PEGS Boston Summit
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : SODIUM OXYBATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.5GM/ML

Packaging :

Approval Date : 2025-11-05

Application Number : 210523

Regulatory Info : RX

Registration Country : USA

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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : SODIUM OXYBATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.5GM/ML

Packaging :

Approval Date : 2025-09-10

Application Number : 203631

Regulatory Info : RX

Registration Country : USA

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : LUMRYZ

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : 4.5GM/PACKET

Packaging :

Approval Date : 2023-05-01

Application Number : 214755

Regulatory Info : RX

Registration Country : USA

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : LUMRYZ

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : 6GM/PACKET

Packaging :

Approval Date : 2023-05-01

Application Number : 214755

Regulatory Info : RX

Registration Country : USA

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05

PEGS Boston Summit
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : LUMRYZ

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : 7.5GM/PACKET

Packaging :

Approval Date : 2023-05-01

Application Number : 214755

Regulatory Info : RX

Registration Country : USA

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06

PEGS Boston Summit
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : LUMRYZ

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : 9GM/PACKET

Packaging :

Approval Date : 2023-05-01

Application Number : 214755

Regulatory Info : RX

Registration Country : USA

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07

PEGS Boston Summit
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PEGS Boston Summit
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Sodium Oxybate

Brand Name : Natrii oxybutyras

Dosage Form : Solution for Injection

Dosage Strength : 200MG/ML

Packaging : 5ML, 10ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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08

PEGS Boston Summit
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PEGS Boston Summit
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Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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09

PEGS Boston Summit
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PEGS Boston Summit
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Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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10

PEGS Boston Summit
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PEGS Boston Summit
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Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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11

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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12

PEGS Boston Summit
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PEGS Boston Summit
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Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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13

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : SODIUM OXYBATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.5GM/ML

Packaging :

Approval Date : 2017-01-17

Application Number : 202090

Regulatory Info : DISCN

Registration Country : USA

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14

PEGS Boston Summit
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : XYREM

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.5GM/ML

Packaging :

Approval Date : 2002-07-17

Application Number : 21196

Regulatory Info : RX

Registration Country : USA

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15

PEGS Boston Summit
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PEGS Boston Summit
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CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Brand Name : XYWAV

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML

Packaging :

Approval Date : 2020-07-21

Application Number : 212690

Regulatory Info : RX

Registration Country : USA

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16

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Gamma-Hydroxybutyric Acid Sodium

Brand Name :

Dosage Form : Extended Release Granules For Oral Suspension

Dosage Strength : 500MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

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17

PEGS Boston Summit
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PEGS Boston Summit
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SODIUM OXYBATE

Brand Name : SODIUM OXYBATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 500MG/ML

Packaging :

Approval Date :

Application Number : 203351

Regulatory Info :

Registration Country : USA

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18

PEGS Boston Summit
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PEGS Boston Summit
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Sodium Oxybase

Brand Name : Xyrem

Dosage Form : Oral Solution

Dosage Strength : 500mg

Packaging :

Approval Date : 09/06/2006

Application Number : 57184

Regulatory Info : Allowed

Registration Country : Switzerland

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19

C.T. LAB.FARMACEUTICO Srl

Country
PEGS Boston Summit
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C.T. LAB.FARMACEUTICO Srl

Country
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PEGS Boston Summit
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Sodium Oxybate

Brand Name : Alcover

Dosage Form : Sodium Oxybate 17.5% 10Ml 12 Combined Oral Use

Dosage Strength : os soluz 12 vials 10 ml 17.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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20

C.T. LAB.FARMACEUTICO Srl

Country
PEGS Boston Summit
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C.T. LAB.FARMACEUTICO Srl

Country
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PEGS Boston Summit
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Sodium Oxybate

Brand Name : Alcover

Dosage Form : Sodium Oxybate 17.5% 140Ml Oral Use

Dosage Strength : os soluz 140 ml 17.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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