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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/23/1976 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/12/2023 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017836s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017836Orig1s009ltr.pdf | |
06/08/2004 | SUPPL-8 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17836scs008ltr.pdf |
05/21/1996 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
02/03/1977 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
02/03/1977 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
02/03/1977 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
10/08/1976 | SUPPL-1 | Supplement |
Label is not available on this site. |
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 |