Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212628
Company: GLAND

Products on ANDA 212628

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 212628

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2021	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
07/13/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212628

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
TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207444	SOMERSET THERAPS LLC
TOBREX	TOBRAMYCIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	062535	SANDOZ