Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 017836
Company: ISO TEX
Company: ISO TEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JEANATOPE | ALBUMIN IODINATED I-125 SERUM | 500uCi/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| JEANATOPE | ALBUMIN IODINATED I-125 SERUM | 1,000uCi/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| JEANATOPE | ALBUMIN IODINATED I-125 SERUM | 100uCi/10ML (10uCi/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017836s009lbl.pdf |