Application 202207
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 414
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LYMPHOSEEK KIT | TECHNETIUM TC-99M TILMANOCEPT | INJECTABLE;INJECTION | N/A | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52579-1600 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Navidea Biopharmaceuticals, Inc. | NDA | Current |
| 52579-1604 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Navidea Biopharmaceuticals, Inc. | NDA | Current |
| 65857-425 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-425 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-425 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-425 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-425 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-450 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-450 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-450 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-450 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
| 65857-450 | Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) | tilmanocept | Cardinal Health 414, LLC | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 67601 | 0 | SUPPL | 12 | 2021-05-26 | Cached in FDA.report object storage |
| 67564 | 0 | SUPPL | 12 | 2021-05-20 | Cached in FDA.report object storage |
| 59306 | 0 | SUPPL | 9 | 2019-07-10 | FDA source fallback |
| 59283 | 0 | SUPPL | 9 | 2019-07-09 | FDA source fallback |
| 47304 | 0 | SUPPL | 5 | 2017-02-24 | Cached in FDA.report object storage |
| 9992 | 0 | SUPPL | 2 | 2014-10-16 | Cached in FDA.report object storage |
| 40138 | 0 | SUPPL | 2 | 2014-10-15 | Cached in FDA.report object storage |
| 9991 | 0 | SUPPL | 1 | 2014-06-18 | Cached in FDA.report object storage |
| 19295 | 0 | SUPPL | 1 | 2014-06-17 | Cached in FDA.report object storage |
| 43389 | 0 | ORIG | 1 | 2013-04-22 | FDA source fallback |
| 24409 | 0 | ORIG | 1 | 2013-04-22 | Cached in FDA.report object storage |
| 19294 | 0 | ORIG | 1 | 2013-03-15 | Cached in FDA.report object storage |
| 9990 | 0 | ORIG | 1 | 2013-03-15 | Cached in FDA.report object storage |