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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064064
Company: BAUSCH AND LOMB

Products on ANDA 064064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/1995	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
02/05/2002	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
11/27/2001	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/07/1999	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/03/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/29/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/30/1999	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1998	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/15/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064064

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

OINTMENT;OPHTHALMIC; 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
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 BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	No	AT	064064	BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT;OPHTHALMIC	Prescription	No	AT	060764	PADAGIS US

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