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01 1Pharmathen SA

02 1Accord healthcare

03 1Ajanta Pharma Limited

04 1Amneal Pharmaceuticals

05 4Avadel Pharmaceuticals

06 2C.T. LAB.FARMACEUTICO Srl

07 9Farmak JSC

08 1Hikma Pharmaceuticals

09 4Jazz Pharmaceuticals

10 3Kalcex

11 1LABORATORIOS NORMON SA

12 1Reig Jofre

13 1Sun Pharmaceutical Industries Limited

14 4UCB Pharma S.A

15 1Zentiva

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info :

Registration Country : Greece

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

Pharmathen

02

ASPEN
Not Confirmed
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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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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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07

ASPEN
Not Confirmed
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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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08

ASPEN
Not Confirmed
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ASPEN
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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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09

ASPEN
Not Confirmed
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ASPEN
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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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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15

ASPEN
Not Confirmed
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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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16

ASPEN
Not Confirmed
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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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17

ASPEN
Not Confirmed
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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

ASPEN
Not Confirmed
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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
ASPEN
Not Confirmed
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C.T. LAB.FARMACEUTICO Srl

Country
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ASPEN
Not Confirmed

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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C.T. LAB.FARMACEUTICO Srl

Country
ASPEN
Not Confirmed
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C.T. LAB.FARMACEUTICO Srl

Country
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ASPEN
Not Confirmed

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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