Details for New Drug Application (NDA): 220313
NDA 220313 describes GLYCEROL PHENYLBUTYRATE, which is a drug marketed by Aurobindo Pharma, Lupin, MSN, Navinta Llc, Pai Holdings, Ph Health, and Teva Pharms Inc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the GLYCEROL PHENYLBUTYRATE profile page.
The generic ingredient in GLYCEROL PHENYLBUTYRATE is glycerol phenylbutyrate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.
The generic ingredient in GLYCEROL PHENYLBUTYRATE is glycerol phenylbutyrate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.
Summary for 220313
| Tradename: | GLYCEROL PHENYLBUTYRATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | glycerol phenylbutyrate |
| Patents: | 0 |
Pharmacology for NDA: 220313
| Mechanism of Action | Ammonium Ion Binding Activity |
Medical Subject Heading (MeSH) Categories for 220313
Suppliers and Packaging for NDA: 220313
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 220313 | ANDA | Aurobindo Pharma Limited | 59651-988 | 59651-988-25 | 1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;ORAL | Strength | 1.1GM/ML | ||||
| Approval Date: | Apr 15, 2026 | TE: | AA | RLD: | No | ||||
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