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Drugs@FDA: FDA-Approved Drugs

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

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 Prescription AT No Yes
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

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.

NEOSPORIN G.U. IRRIGANT

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

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
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