Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065121
Company: PADAGIS US

Products on ANDA 065121

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2004	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
07/11/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065121

GENTAMICIN SULFATE

SOLUTION/DROPS;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	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	064048	BAUSCH AND LOMB
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	065121	PADAGIS US
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	062196	SANDOZ