Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065219
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 HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | 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 |
---|---|---|---|---|---|---|---|
05/01/2006 | ORIG-1 | Approval |
Label is not available on this site. |
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
SUSPENSION/DROPS;OTIC; 1%;EQ 3.5MG 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 |
---|---|---|---|---|---|---|---|---|
CASPORYN HC | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | Yes | AT | 060613 | CASPER PHARMA LLC |
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 065219 | AMRING PHARMS |
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 062488 | SANDOZ |
OTICAIR | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 064065 | BAUSCH AND LOMB |