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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 214860


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NDA 214860 describes OLPRUVA, which is a drug marketed by Acer and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OLPRUVA profile page.

The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 214860
Tradename:OLPRUVA
Applicant:Acer
Ingredient:sodium phenylbutyrate
Patents:3
Suppliers and Packaging for NDA: 214860
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860 NDA Acer Therapeutics Inc. 72542-200 72542-200-09 90 BOX in 1 CARTON (72542-200-09) / 1 KIT in 1 BOX (72542-200-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)
OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860 NDA Acer Therapeutics Inc. 72542-300 72542-300-09 90 BOX in 1 CARTON (72542-300-09) / 1 KIT in 1 BOX (72542-300-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength2GM/PACKET
Approval Date:Dec 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A UREA CYCLE DISORDER INVOLVING DEFICIENCIES OF CARBAMYLPHOSPHATE SYNTHETASE, ORNITHINE TRANSCARBAMYLASE, OR ARGININOSUCCINIC ACID SYNTHETASE
Patent:⤷  Sign UpPatent Expiration:Oct 17, 2036Product Flag?YSubstance Flag?Delist Request?

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