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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. Two 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 |
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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