Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065187
Company: AMRING PHARMS
Company: AMRING PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | 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 |
---|---|---|---|---|---|---|---|
10/28/2005 | ORIG-1 | Approval |
Label is not available on this site. |
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
SOLUTION/DROPS;OPHTHALMIC; 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 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 SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 065187 | AMRING PHARMS |
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064047 | BAUSCH AND LOMB |
NEOSPORIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 060582 | MONARCH PHARMS |