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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062423
Company: SANDOZ

Products on ANDA 062423

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS;OTIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062423

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/1983	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
12/24/2002	SUPPL-28	Labeling		Label is not available on this site.
12/23/2002	SUPPL-27	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/24/2002	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
12/24/2002	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
12/24/2002	SUPPL-24	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/24/2002	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/19/1999	SUPPL-20	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-19	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/16/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/14/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/27/1993	SUPPL-16	Labeling		Label is not available on this site.
12/03/1993	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/23/1991	SUPPL-14	Labeling		Label is not available on this site.
01/27/1989	SUPPL-13	Labeling		Label is not available on this site.
11/08/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062423

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

SOLUTION/DROPS;OTIC; 1%;EQ 3.5MG 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 HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS;OTIC	Prescription	No	AT	064053	BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS;OTIC	Prescription	No	AT	062423	SANDOZ

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