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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065220
Company: XGEN PHARMS

Products on ANDA 065220

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065220

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2006	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
02/10/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065220

NEOMYCIN SULFATE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	No	AA	060304	TEVA
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	No	AA	065220	XGEN PHARMS

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