Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065024
Company: FERA PHARMS LLC

Products on ANDA 065024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2004	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065024_S000_Gentamicin Ophthalmic OintmentTOC.html

Therapeutic Equivalents for ANDA 065024

GENTAMICIN SULFATE

OINTMENT;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT;OPHTHALMIC	Prescription	No	AT	065024	FERA PHARMS LLC