Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017279
Company: ISOTEX
Company: ISOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLOFIL-125 | IOTHALAMATE SODIUM I-125 | 250-300uCi/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 |
|---|---|---|---|---|---|---|---|
| 02/12/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17279s8ltr.pdf |
| 03/27/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/16/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |