Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075005
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
02/24/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75005ap.pdf |