Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065120
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG 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 |
---|---|---|---|---|---|---|---|
11/29/2002 | 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-10 | Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/21/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |
TOBRAMYCIN SULFATE (PHARMACY BULK)
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 |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206965 | BAXTER HLTHCARE CORP |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065122 | FRESENIUS KABI USA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209621 | GLAND PHARMA LTD |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063117 | HIKMA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063111 | HOSPIRA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065407 | MYLAN LABS LTD |
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065120 | FRESENIUS KABI USA |
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209346 | GLAND PHARMA LTD |