Application 202207
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 414
Application Products#
Product, Drug, Ingredient table| 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 table| 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, Submission type, Date table| Document | Submission type | Date |
|---|
| 67601 | SUPPL | 2021-05-26 |
| 67564 | SUPPL | 2021-05-20 |
| 59306 | SUPPL | 2019-07-10 |
| 59283 | SUPPL | 2019-07-09 |
| 47304 | SUPPL | 2017-02-24 |
| 9992 | SUPPL | 2014-10-16 |
| 40138 | SUPPL | 2014-10-15 |
| 9991 | SUPPL | 2014-06-18 |
| 19295 | SUPPL | 2014-06-17 |
| 43389 | ORIG | 2013-04-22 |
| 24409 | ORIG | 2013-04-22 |
| 19294 | ORIG | 2013-03-15 |
| 9990 | ORIG | 2013-03-15 |