Details for New Drug Application (NDA): 020573
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The generic ingredient in BUPHENYL 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 020573
Tradename: | BUPHENYL |
Applicant: | Horizon Therap Us |
Ingredient: | sodium phenylbutyrate |
Patents: | 0 |
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 Therapeutics USA, 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 Us | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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