Details for New Drug Application (NDA): 020572
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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 020572
Tradename: | BUPHENYL |
Applicant: | Horizon Therap Us |
Ingredient: | sodium phenylbutyrate |
Patents: | 0 |
Pharmacology for NDA: 020572
Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 020572
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572 | NDA | Horizon Therapeutics USA, Inc. | 75987-060 | 75987-060-08 | 1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | May 13, 1996 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020572
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Horizon Therap Us | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | 4,457,942 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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