Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065216
Company: SAPTALIS PHARMS

Products on ANDA 065216

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2005	ORIG-1	Approval				Label is not available on this site.