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 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/04/1983 | 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-45 | Labeling-Package Insert |
Label is not available on this site. |
||
02/10/2023 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
02/10/2023 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
03/07/2014 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf | |
03/09/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/03/2004 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
12/05/2002 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/28/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/07/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/22/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
08/27/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/06/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
09/11/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
06/19/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/07/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf |
GENTAMICIN SULFATE
INJECTABLE;INJECTION; EQ 40MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215237 | EUGIA PHARMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062366 | FRESENIUS KABI USA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062251 | HIKMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062420 | HOSPIRA |
INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215236 | EUGIA PHARMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062366 | FRESENIUS KABI USA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062251 | HIKMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062420 | HOSPIRA |