Application 214018
- Type
- NDA
- Sponsor
- ORIGIN BIOSCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NULIBRY | FOSDENOPTERIN | INJECTABLE;INJECTION | 9.5MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73129-001 | Nulibry | fosdenopterin hydrobromide | Origin Biosciences, Inc. | NDA | Current |
| 73129-001 | Nulibry | fosdenopterin hydrobromide | Origin Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72526 | SUPPL | 2022-11-01 |
| 72492 | SUPPL | 2022-10-28 |
| 66883 | ORIG | 2021-03-26 |
| 66416 | ORIG | 2021-03-01 |
| 66410 | ORIG | 2021-02-26 |