Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060582
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSPORIN GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS;OPHTHALMIC Prescription AT No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/03/1968 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060582_original_approval_package.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2006 SUPPL-9 Labeling

Label is not available on this site.

07/23/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-6 Labeling

Label is not available on this site.

NEOSPORIN

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

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