Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217803
Company: AMNEAL

Products on ANDA 217803

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 217803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217803

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	217803	AMNEAL
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 INC
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