← FDA Drug Approvals (Drugs@FDA)
BUPHENYL
NDA · New Drug Application · Sponsor: HORIZON THERAP US · Approved 1996-04-30
Drug application
- FDA Application #
NDA020573
- Application type
- New Drug Application
- Brand name
- BUPHENYL
- Generic name
- SODIUM PHENYLBUTYRATE
- Active ingredients
- SODIUM PHENYLBUTYRATE
- Dosage form
- POWDER
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- HORIZON THERAP US
- Manufacturer
- Horizon Therapeutics USA, Inc.
- First approval
- 1996-04-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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