Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
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 |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG 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 |
---|---|---|---|---|---|---|---|
03/04/1982 | 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 |
---|---|---|---|---|---|
09/11/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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07/26/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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03/09/2005 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/03/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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03/07/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/21/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
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02/23/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/06/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/07/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/18/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |