Application 761169
- Type
- BLA
- Sponsor
- REGENERON PHARMACEUTICALS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INMAZEB | ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB | SOLUTION; INJECTION | 16.7MG/1ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61755-018 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-018 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-018 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-018 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-018 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-019 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-019 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-019 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80015 | SUPPL | 2024-10-28 |
| 79986 | SUPPL | 2024-10-25 |
| 73765 | SUPPL | 2023-03-15 |
| 73764 | SUPPL | 2023-03-15 |
| 71082 | SUPPL | 2022-05-16 |
| 71072 | SUPPL | 2022-05-16 |
| 65202 | ORIG | 2020-11-12 |
| 64925 | ORIG | 2020-10-15 |
| 64924 | ORIG | 2020-10-15 |