Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065026
Company: CHARTWELL RX

Products on ANDA 065026

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065026

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65026ltr.pdf

Therapeutic Equivalents for ANDA 065026

TOBRAMYCIN

SOLUTION/DROPS;OPHTHALMIC; 0.3%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	211847	ALEMBIC
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	064052	BAUSCH AND LOMB
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	065026	CHARTWELL RX
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	212628	GLAND PHARMA LTD
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207444	SOMERSET THERAPS LLC
TOBREX	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	050541	NOVARTIS
TOBREX	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	062535	SANDOZ