Application 103770
- Type
- BLA
- Sponsor
- MEDIMMUNE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYNAGIS | PALIVIZUMAB | VIAL | 100MG/VIAL | No | No |
| 002 | SYNAGIS | PALIVIZUMAB | VIAL | 50MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60574-4113 | Synagis | palivizumab | MedImmune, LLC | BLA | Current |
| 60574-4114 | Synagis | palivizumab | MedImmune, LLC | BLA | Current |
| 66658-230 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
| 66658-230 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
| 66658-230 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
| 66658-231 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
| 66658-231 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
| 66658-231 | Synagis | palivizumab | Swedish Orphan Biovitrum AB (publ) | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72750 | APPL | 2022-11-30 |
| 48408 | SUPPL | 2017-05-17 |
| 48384 | SUPPL | 2017-05-16 |
| 18629 | SUPPL | 2014-03-25 |
| 31637 | SUPPL | 2014-03-24 |
| 43280 | SUPPL | 2013-08-09 |
| 22744 | SUPPL | 2013-08-09 |
| 18628 | SUPPL | 2012-04-06 |
| 9434 | SUPPL | 2012-04-06 |
| 9433 | SUPPL | 2011-05-17 |
| 18627 | SUPPL | 2009-03-24 |
| 9432 | SUPPL | 2009-03-24 |
| 18626 | SUPPL | 2008-11-20 |
| 9431 | SUPPL | 2008-08-05 |
| 39690 | SUPPL | 2007-03-07 |
| 31636 | SUPPL | 2007-03-06 |
| 9430 | SUPPL | 2005-03-03 |
| 39689 | SUPPL | 2004-12-22 |
| 39688 | SUPPL | 2004-03-29 |
| 31635 | SUPPL | 2004-03-29 |
| 31634 | ORIG | 2004-03-29 |
| 22743 | ORIG | 2004-03-29 |