Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074636
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IOPAMIDOL-200 IN PLASTIC CONTAINER | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Discontinued | None | No | No |
IOPAMIDOL-250 IN PLASTIC CONTAINER | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Discontinued | None | No | No |
IOPAMIDOL-300 IN PLASTIC CONTAINER | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Discontinued | None | No | No |
IOPAMIDOL-370 IN PLASTIC CONTAINER | 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 |
---|---|---|---|---|---|---|---|
12/30/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/01/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |