Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065106
Company: XGEN PHARMS

Products on ANDA 065106

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065106

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.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065106

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