Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080224
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SORBITOL-MANNITOL | MANNITOL; SORBITOL | 540MG/100ML;2.7GM/100ML | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 08/20/1971 | 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 |
|---|---|---|---|---|---|
| 05/20/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |