Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060707
Company: MONARCH PHARMS

Products on ANDA 060707

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOSPORIN G.U. IRRIGANT	NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION;IRRIGATION	Discontinued	None	No	No
NEOSPORIN G.U. IRRIGANT	NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML)	SOLUTION; IRRIGATION	Prescription	AT	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060707

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1966	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
07/23/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/18/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 060707

NEOSPORIN G.U. IRRIGANT

SOLUTION; IRRIGATION; EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (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
NEOSPORIN G.U. IRRIGANT	NEOMYCIN SULFATE; POLYMYXIN B SULFATE	EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML)	SOLUTION; IRRIGATION	Prescription	Yes	AT	060707	MONARCH PHARMS