Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074741
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1997 | 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 |
|---|---|---|---|---|---|
| 04/11/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/04/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |