Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.4MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.8MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 60MG BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 70MG BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 90MG BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/15/1983 | 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 |
---|---|---|---|---|---|
02/10/2023 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
06/23/2016 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
04/19/2004 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
11/01/2002 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/01/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/18/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/08/1997 | SUPPL-24 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/12/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/1996 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/25/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
10/04/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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03/10/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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01/18/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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08/02/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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01/06/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/22/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; EQ 1.2MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062373 | BAXTER HLTHCARE |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062414 | HOSPIRA |
INJECTABLE;INJECTION; EQ 1.6MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062373 | BAXTER HLTHCARE |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062414 | HOSPIRA |
INJECTABLE;INJECTION; EQ 80MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 062373 | BAXTER HLTHCARE |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 062414 | HOSPIRA |
INJECTABLE;INJECTION; EQ 100MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 062373 | BAXTER HLTHCARE |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 062414 | HOSPIRA |