PHENYLBUTYRIC ACID Pharmacologic Class Indexing
- Class set ID
- ad41caeb-4596-4baa-83fb-bcbe1286900a
- Version
- 2
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| Sodium Phenylbutyrate Tablets, USP Rx only | Zydus Pharmaceuticals USA Inc. | Navinta LLC | 20260428 | 2 |
| Sodium Phenylbutyrate Tablets, USP Rx only | Par Health USA, LLC | 20260417 | 10 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Novadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc. | 20260416 | 1 |
| Sodium Phenylbutyrate Powder, USP Rx Only | Par Health USA, LLC | 20260414 | 10 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Aurobindo Pharma Limited | 20260409 | 1 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Zydus Pharmaceuticals USA Inc. | Navinta LLC | Apothecon Pharmaceuticals Pvt Ltd | 20260401 | 1 |
| Sodium Phenylbutyrate Tablets, USP | GLENMARK PHARMACEUTICALS INC., USA | Glenmark Pharmaceuticals Limited | 20260128 | 3 |
| These highlights do not include all the information needed to use PHEBURANE safely and effectively. See full prescribing information for PHEBURANE. PHEBURANE ® (sodium phenylbutyrate) oral pellets Initial U.S. Approval: 1996 | Medunik USA | 20251126 | 6 |
| These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996 | Horizon Therapeutics USA, Inc. | 20251029 | 13 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Par Health USA, LLC | 20251009 | 23 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Lupin Pharmaceuticals, Inc. | 20250630 | 1 |
| These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996 | Teva Pharmaceuticals, Inc. | 20250301 | 1 |
| These highlights do not include all the information needed to use OLPRUVA TM safely and effectively. See full prescribing information for OLPRUVA. OLPRUVA (sodium phenylbutyrate) for oral suspension Initial U.S. Approval: 1996 | Acer Therapeutics Inc. | CH Chemie Uetikon GmbH | EMSL Analytical, Inc. DBA MPL Laboratories | Glatt Air Techniques Inc. | Sharp Clinical Services LLC | 20241218 | 4 |
| BUPHENYL ® (sodium phenylbutyrate) Tablets BUPHENYL ® (sodium phenylbutyrate) Powder | Horizon Therapeutics USA, Inc. | 20241030 | 9 |
| Sodium Phenylbutyrate Powder (SO-dee-um fen-ill-BYOU-tih-rate) Rx Only | Sigmapharm Laboratories, LLC | 20220202 | 5 |