Application 017836
- Type
- BLA
- Sponsor
- ISO TEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | JEANATOPE | ALBUMIN IODINATED I-125 SERUM | INJECTABLE;INJECTION | 500uCi/0.5ML | No | No |
| 002 | JEANATOPE | ALBUMIN IODINATED I-125 SERUM | INJECTABLE;INJECTION | 1,000uCi/ML | No | No |
| 003 | JEANATOPE | ALBUMIN IODINATED I-125 SERUM | INJECTABLE;INJECTION | 100uCi/10ML (10uCi/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50914-7732 | Jeanatope | Iodinated I-125 Albumin | Iso-Tex Diagnostics, Inc. | BLA | Current |
| 50914-7732 | Jeanatope | Iodinated I-125 Albumin | Iso-Tex Diagnostics, Inc. | NDA | Current |
| 50914-7732 | Jeanatope | Iodinated I-125 Albumin | Iso-Tex Diagnostics, Inc. | NDA | Current |
| 50914-7733 | Jeanatope | Iodinated I-125 Albumin | Iso-Tex Diagnostics, Inc. | BLA | Current |