Application 019818
- Type
- BLA
- Sponsor
- LEADIANT BIOSCI INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 019818 | Adagen | pegademase bovine | 351(a) | Disc | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADAGEN | PEGADEMASE BOVINE | INJECTABLE;INJECTION | 250 UNITS/ML | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 1 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57665-001 | Adagen | pegademase bovine | Leadiant Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66396 | APPL | 2020-03-23 |
| 33983 | SUPPL | 2020-03-23 |
| 19258 | SUPPL | 2020-03-23 |
| 19257 | SUPPL | 2020-03-23 |
| 11739 | SUPPL | 2020-03-23 |
| 11738 | SUPPL | 2020-03-23 |
| 1645 | SUPPL | 2020-03-23 |