Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065121
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
01/30/2004 | 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 |
---|---|---|---|---|---|
07/11/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
GENTAMICIN SULFATE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064048 | BAUSCH AND LOMB |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 065121 | PADAGIS US |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062196 | SANDOZ |