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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214860
Company: ACER

Products on NDA 214860

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLPRUVA	SODIUM PHENYLBUTYRATE	2GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	3GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
OLPRUVA	SODIUM PHENYLBUTYRATE	6GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	6.67GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	0.5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
OLPRUVA	SODIUM PHENYLBUTYRATE	1GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214860

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214860s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214860Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214860Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-7	Labeling-Package Insert, Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214860s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214860Orig1s007ltr.pdf

Labels for NDA 214860

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214860s007lbl.pdf
10/10/2025	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214860s007lbl.pdf
12/22/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214860s000lbl.pdf

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