Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050789
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | 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 |
---|---|---|---|---|---|---|---|
07/13/2004 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50789ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050789s000_TobramycinTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/10/2009 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050789s027ltr.pdf |
02/10/2023 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050789s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050789Orig1s017ltr.pdf | |
04/15/2021 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050789s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050789Orig1s012ltr.pdf | |
02/16/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050789Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050789Orig1s006ltr.pdf | |
08/10/2009 | SUPPL-5 | Labeling |
Label (PDF)
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/10/2023 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050789s017lbl.pdf | |
04/15/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050789s012lbl.pdf | |
04/03/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050789Orig1s006lbl.pdf | |
08/10/2009 | SUPPL-5 | Labeling | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf |
07/13/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf |
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION; EQ 1.2GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217519 | EUGIA PHARMA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 050789 | FRESENIUS KABI USA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211189 | GLAND PHARMA LTD |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217029 | HAINAN POLY |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205685 | XELLIA PHARMS APS |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 1.2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065013 | XGEN PHARMS |