Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065024
Company: FERA PHARMS LLC
Company: FERA PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
07/30/2004 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065024_S000_Gentamicin Ophthalmic OintmentTOC.cfm |
GENTAMICIN SULFATE
OINTMENT;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 | OINTMENT;OPHTHALMIC | Prescription | No | AT | 065024 | FERA PHARMS LLC |