Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074881
Company: COOK IMAGING
Company: COOK IMAGING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IOPAMIDOL-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IOPAMIDOL-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IOPAMIDOL-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IOPAMIDOL-370 | IOPAMIDOL | 76% | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74881ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/17/2001 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |