Suppliers and packages for generic ingredient: SODIUM PHENYLBUTYRATE
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SODIUM PHENYLBUTYRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 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) | 2022-12-22 |
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 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) | 2022-12-22 |
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 72542-400-18 | 90 BOX in 1 CARTON (72542-400-18) / 1 KIT in 1 BOX (72542-400-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) | 2022-12-22 |
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 72542-500-18 | 90 BOX in 1 CARTON (72542-500-18) / 1 KIT in 1 BOX (72542-500-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) | 2022-12-22 |
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 72542-600-18 | 90 BOX in 1 CARTON (72542-600-18) / 1 KIT in 1 BOX (72542-600-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) | 2022-12-22 |
| Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860 | NDA | Acer Therapeutics Inc. | 72542-667-18 | 90 BOX in 1 CARTON (72542-667-18) / 1 KIT in 1 BOX (72542-667-02) * 1 FOR SUSPENSION in 1 PACKET (72542-367-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) | 2022-12-22 |
| Medunik | PHEBURANE | sodium phenylbutyrate | PELLETS;ORAL | 216513 | NDA | Medunik USA | 71770-200-10 | 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10) | 2022-08-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
