Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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09/25/1998 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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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. |
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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. |
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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. |
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06/20/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |