Details for New Drug Application (NDA): 214860
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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: | ⤷ Sign Up | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Oct 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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