Application 203284
- Type
- NDA
- Sponsor
- HORIZON THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RAVICTI | GLYCEROL PHENYLBUTYRATE | LIQUID;ORAL | 1.1GM/ML | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75987-050 | Ravicti | glycerol phenylbutyrate | Horizon Therapeutics, Inc. | NDA | Current |
| 75987-050 | Ravicti | glycerol phenylbutyrate | Horizon Therapeutics, Inc. | NDA | Current |
| 75987-050 | Ravicti | glycerol phenylbutyrate | Horizon Therapeutics, Inc. | NDA | Current |
| 75987-050 | Ravicti | glycerol phenylbutyrate | Horizon Therapeutics, LLC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 68580 | SUPPL | 2021-09-10 |
| 68577 | SUPPL | 2021-09-10 |
| 68551 | SUPPL | 2021-09-08 |
| 60482 | SUPPL | 2019-10-09 |
| 60252 | SUPPL | 2019-10-07 |
| 60251 | SUPPL | 2019-10-07 |
| 57063 | SUPPL | 2018-12-30 |
| 57029 | SUPPL | 2018-12-26 |
| 57028 | SUPPL | 2018-12-26 |
| 48283 | SUPPL | 2017-05-08 |
| 48181 | SUPPL | 2017-05-02 |
| 48174 | SUPPL | 2017-05-01 |
| 45291 | SUPPL | 2016-09-12 |
| 45266 | SUPPL | 2016-09-09 |
| 10194 | SUPPL | 2014-07-08 |
| 40285 | SUPPL | 2014-07-03 |
| 22919 | ORIG | 2013-03-28 |
| 40284 | ORIG | 2013-02-06 |
| 32405 | ORIG | 2013-02-04 |