Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065187
Company: AMRING PHARMS

Products on ANDA 065187

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065187

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.

Therapeutic Equivalents for ANDA 065187

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