Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062373
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| 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 0.8MG BASE/ML | 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 40MG BASE/100ML | 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 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 120MG BASE/100ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
| 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 1.6MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2.4MG 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 |
|---|---|---|---|---|---|---|---|
| 09/07/1982 | 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 |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2023 | SUPPL-42 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/31/2023 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/05/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/31/2004 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/29/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/06/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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 |
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 |
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 |
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 |