Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211189
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
05/18/2021 | ORIG-1 | Approval | STANDARD |
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-1 | Labeling-Package Insert |
Label is not available on this site. |
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 |