Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074598
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 10MG/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 |
|---|---|---|---|---|---|---|---|
| 06/19/1997 | 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 |
|---|---|---|---|---|---|
| 08/29/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |