Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207444
Company: SOMERSET THERAPS LLC

Products on ANDA 207444

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 207444

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/20/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/20/2024	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 207444

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