Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065108
Company: XGEN PHARMS
Company: XGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | 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 |
---|---|---|---|---|---|---|---|
01/31/2006 | ORIG-1 | Approval |
Label is not available on this site. |
NEOMYCIN AND POLYMYXIN B SULFATE
SOLUTION;IRRIGATION; EQ 40MG BASE/ML;200,000 UNITS/ML
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 062664 | WATSON LABS |
NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 065106 | XGEN PHARMS |
NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 065108 | XGEN PHARMS |
NEOSPORIN G.U. IRRIGANT | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 060707 | MONARCH PHARMS |