Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062612
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG 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 |
|---|---|---|---|---|---|---|---|
| 02/20/1986 | 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 |
|---|---|---|---|---|---|
| 03/24/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/06/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/09/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 01/14/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |