Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020652
Company: IC TARGETS
Company: IC TARGETS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESLASCAN | MANGAFODIPIR TRISODIUM | 37.9MG/ML | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 07/08/2002 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20652s003ltr.pdf |
| 03/26/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |