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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064047
Company: BAUSCH AND LOMB

Products on ANDA 064047

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/1996	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
10/30/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/27/2001	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/30/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/18/2000	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/07/1999	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/19/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/19/1998	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1998	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/24/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/24/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/20/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064047

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

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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