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01 6ACER

02 1ALVOGEN

03 2ENDO OPERATIONS

04 1GLENMARK PHARMS LTD

05 2HORIZON THERAP US

06 1MEDUNIK

07 1SIGMAPHARM LABS LLC

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
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SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 2GM/PACKET

Approval Date : 2022-12-22

Application Number : 214860

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 3GM/PACKET

Approval Date : 2022-12-22

Application Number : 214860

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 4GM/PACKET

Approval Date : 2022-12-22

Application Number : 214860

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : OLPRUVA

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 5GM/PACKET

Approval Date : 2022-12-22

Application Number : 214860

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : SODIUM PHENYLBUTYRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2011-11-18

Application Number : 90910

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : BUPHENYL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1996-05-13

Application Number : 20572

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : BUPHENYL

Dosage Form : POWDER;ORAL

Dosage Strength : 3GM/TEASPOONFUL

Approval Date : 1996-04-30

Application Number : 20573

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : SODIUM PHENYLBUTYRATE

Dosage Form : POWDER;ORAL

Dosage Strength : 3GM/TEASPOONFUL

Approval Date : 2013-03-22

Application Number : 202819

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : SODIUM PHENYLBUTYRATE

Dosage Form : POWDER;ORAL

Dosage Strength : 3GM/TEASPOONFUL

Approval Date : 2016-06-15

Application Number : 203918

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
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Antibody Engineering
Not Confirmed

SODIUM PHENYLBUTYRATE

Brand Name : SODIUM PHENYLBUTYRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2016-04-15

Application Number : 204395

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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