Application 213491
- Type
- NDA
- Sponsor
- HORIZON PHARMA USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROCYSBI | CYSTEAMINE BITARTRATE | GRANULE;ORAL | EQ 75MG BASE/PACKET | Yes | No |
| 002 | PROCYSBI | CYSTEAMINE BITARTRATE | GRANULE;ORAL | EQ 300MG BASE/PACKET | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75987-140 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-140 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-140 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-140 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-140 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-145 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-145 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-145 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-145 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-145 | PROCYSBI | Cysteamine bitartrate | Horizon Therapeutics USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70166 | SUPPL | 2022-02-15 |
| 70158 | SUPPL | 2022-02-14 |
| 63335 | ORIG | 2020-05-29 |
| 61912 | ORIG | 2020-02-19 |
| 61906 | ORIG | 2020-02-18 |