Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214860

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OLPRUVA (SODIUM PHENYLBUTYRATE)
0.5GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 0.5GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 007
Approval Date: Oct 10, 2025
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
1GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 1GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 008
Approval Date: Oct 10, 2025
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
2GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 2GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 001
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
3GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 3GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 002
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
4GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 4GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 003
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
5GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 5GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214860
Product Number: 004
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
6GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 6GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 005
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLPRUVA (SODIUM PHENYLBUTYRATE)
6.67GM/PACKET
Marketing Status: Prescription

Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: OLPRUVA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 6.67GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214860
Product Number: 006
Approval Date: Dec 22, 2022
Applicant Holder Full Name: ACER THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information