Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064054
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
04/29/1994 | ORIG-1 | Approval |
Label is not available on this site. |
GENTAMICIN SULFATE
OINTMENT;TOPICAL; EQ 0.1% 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 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 064054 | COSETTE |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062533 | FOUGERA PHARMS INC |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062351 | PADAGIS US |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062477 | TARO |