Application 020572
- Type
- NDA
- Sponsor
- HORIZON THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPHENYL | SODIUM PHENYLBUTYRATE | TABLET;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75987-060 | BUPHENYL | sodium phenylbutyrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-060 | BUPHENYL | sodium phenylbutyrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-060 | BUPHENYL | sodium phenylbutyrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-060 | BUPHENYL | sodium phenylbutyrate | Horizon Pharma, Inc. | NDA | Current |