Synagis Purple Book BLA 103770
- BLA number
- 103770
- Proprietary names
- Synagis
- Proper names
- palivizumab
- Applicant
- Swedish Orphan Biovitrum AB (publ)
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Synagis | palivizumab | 351(a) | 50MG | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | 1998-06-19 | |
| 002 | Synagis | palivizumab | 351(a) | 100MG | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | 1998-06-19 | |
| 003 | Synagis | palivizumab | 351(a) | 50MG/0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | 2004-07-23 | |
| 004 | Synagis | palivizumab | 351(a) | 100MG/1ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | 2004-07-23 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2020-11-01 | U | 001 | Synagis | 351(a) | Disc | Swedish Orphan Biovitrum AB (publ) |
| 2020-11-01 | U | 002 | Synagis | 351(a) | Disc | Swedish Orphan Biovitrum AB (publ) |
| 2020-11-01 | U | 003 | Synagis | 351(a) | Rx | Swedish Orphan Biovitrum AB (publ) |
| 2020-11-01 | U | 004 | Synagis | 351(a) | Rx | Swedish Orphan Biovitrum AB (publ) |
| 2020-05-01 | R | 001 | Synagis | 351(a) | Disc | MedImmune, LLC |
| 2020-05-01 | R | 002 | Synagis | 351(a) | Disc | MedImmune, LLC |
| 2020-05-01 | R | 003 | Synagis | 351(a) | Rx | MedImmune, LLC |
| 2020-05-01 | R | 004 | Synagis | 351(a) | Rx | MedImmune, LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Synagis | 351(a) | Disc | Licensed | 1998-06-19 |
| 2020-05-01 | 002 | Synagis | 351(a) | Disc | Licensed | 1998-06-19 |
| 2020-05-01 | 003 | Synagis | 351(a) | Rx | Licensed | 2004-07-23 |
| 2020-05-01 | 004 | Synagis | 351(a) | Rx | Licensed | 2004-07-23 |