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Approved Drug Products containing Sodium 4-Phenylbutyrate listed in the FDA Orange Book. Original Data : FDA Website

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01 ACER (6)

02 ALVOGEN (1)

03 GLENMARK PHARMS LTD (1)

04 HORIZON THERAP US (2)

05 MEDUNIK (1)

06 PAR PHARM (2)

07 SIGMAPHARM LABS LLC (1)

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01 FOR SUSPENSION;ORAL (6)

02 PELLETS;ORAL (1)

03 POWDER;ORAL (3)

04 TABLET;ORAL (4)

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01 DISCN (1)

02 RX (13)

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01 BUPHENYL (2)

02 OLPRUVA (6)

03 PHEBURANE (1)

04 SODIUM PHENYLBUTYRATE (5)

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01 No (5)

02 Yes (9)

URL Supplier Web Content
FOR SUSPENSION;ORAL
2GM/PACKET
2022-12-22
214860
OLPRUVA
RX
Yes
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FOR SUSPENSION;ORAL
3GM/PACKET
2022-12-22
214860
OLPRUVA
RX
Yes
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FOR SUSPENSION;ORAL
4GM/PACKET
2022-12-22
214860
OLPRUVA
RX
Yes
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FOR SUSPENSION;ORAL
5GM/PACKET
2022-12-22
214860
OLPRUVA
RX
Yes
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TABLET;ORAL
500MG
2011-11-18
90910
SODIUM PHENYLBUTYRATE
DISCN
No
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TABLET;ORAL
500MG
1996-05-13
20572
BUPHENYL
RX
Yes
AB
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POWDER;ORAL
3GM/TEASPOONFUL
1996-04-30
20573
BUPHENYL
RX
Yes
AB
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POWDER;ORAL
3GM/TEASPOONFUL
2016-06-15
203918
SODIUM PHENYLBUTYRATE
RX
No
AB
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TABLET;ORAL
500MG
2016-04-15
204395
SODIUM PHENYLBUTYRATE
RX
No
AB
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POWDER;ORAL
3GM/TEASPOONFUL
2013-03-22
202819
SODIUM PHENYLBUTYRATE
RX
No
AB
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