01 6ACER
02 1ALVOGEN
03 2ENDO OPERATIONS
04 1GLENMARK PHARMS LTD
05 2HORIZON THERAP US
06 1MEDUNIK
07 1SIGMAPHARM LABS LLC
01 6FOR SUSPENSION;ORAL
02 1PELLETS;ORAL
03 3POWDER;ORAL
04 4TABLET;ORAL
01 1DISCN
02 13RX
01 2BUPHENYL
02 6OLPRUVA
03 1PHEBURANE
04 5SODIUM PHENYLBUTYRATE
01 5No
02 9Yes
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : No
TE Code :
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 :
RLD : Yes
TE Code : AB
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
RLD : Yes
TE Code : AB
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
RLD : No
TE Code : AB
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
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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