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Details for New Drug Application (NDA): 020573
NDA 020573 describes BUPHENYL, which is a drug marketed by Horizon Therap and is included in two NDAs. It is available from one supplier. Additional details are available on the BUPHENYL profile page.
The generic ingredient in BUPHENYL is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
The generic ingredient in BUPHENYL is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 020573
| Tradename: | BUPHENYL |
| Applicant: | Horizon Therap |
| Ingredient: | sodium phenylbutyrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020573
| Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 020573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573 | NDA | Horizon Pharma, Inc. | 75987-070 | 75987-070-09 | 1 BOTTLE in 1 CARTON (75987-070-09) > 250 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 3GM/TEASPOONFUL | ||||
| Approval Date: | Apr 30, 1996 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020573
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon Therap | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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