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. 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. Five suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate 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. Five 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2GM/PACKET | ||||
| Approval Date: | Dec 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 11,154,521 | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,202,767 | Patent Expiration: | Oct 17, 2036 | Product 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: | 11,433,041 | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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