Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063264
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 11/30/1994 | 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 |
|---|---|---|---|---|---|
| 03/10/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/13/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/25/2002 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/27/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 03/22/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |