Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060582
Company: MONARCH PHARMS

Products on ANDA 060582

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060582

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.

Therapeutic Equivalents for ANDA 060582

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