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.
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 |
| Formulation / Manufacturing: | see details |
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: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2GM/PACKET | ||||
| Approval Date: | Dec 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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