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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062488
Company: SANDOZ

Products on ANDA 062488

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	SUSPENSION/DROPS;OTIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/1985	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/62488_Neomycin.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/24/2002	SUPPL-21	Labeling		Label is not available on this site.
12/23/2002	SUPPL-20	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/24/2002	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
12/24/2002	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/24/2002	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/24/2002	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
12/24/2002	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/19/1999	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/16/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/25/1994	SUPPL-8	Labeling		Label is not available on this site.
03/14/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/18/1992	SUPPL-6	Labeling		Label is not available on this site.
02/28/1991	SUPPL-5	Labeling		Label is not available on this site.
01/10/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/27/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062488

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

SUSPENSION/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
CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	Yes	AT	060613	CASPER PHARMA LLC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	065219	AMRING PHARMS
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	062488	SANDOZ
OTICAIR	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OTIC	Prescription	No	AT	064065	BAUSCH AND LOMB

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