Generic for Tobrex: Tobramycin

Yes. The generic name for Tobrex is tobramycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Tobrex products the Orange Book lists.

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Tobrex products in the Orange Book

Tobrex products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
ointment, ophthalmic	0.3%	Marketed (Rx)	None	0	None
solution/drops, ophthalmic	0.3%	Discontinued	None	6	AT

NDA 050555, 050541, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tobramycin

Approved generic versions of Tobrex
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	062535	AT (A-rated, therapeutically equivalent)	December 13, 1984	0.3%
BAUSCH AND LOMB INC	064052	AT (A-rated, therapeutically equivalent)	November 29, 1993	0.3%
CHARTWELL RX SCIENCES LLC	065026	AT (A-rated, therapeutically equivalent)	September 11, 2001	0.3%
SOMERSET THERAPEUTICS LLC	207444	AT (A-rated, therapeutically equivalent)	June 28, 2017	0.3%
ALEMBIC PHARMACEUTICALS LTD	211847	AT (A-rated, therapeutically equivalent)	April 19, 2019	0.3%
GLAND PHARMA LTD	212628	AT (A-rated, therapeutically equivalent)	March 9, 2021	0.3%

Tobrex NDC codes

0078-0813

Questions

Is there a generic for Tobrex?

Yes. The generic name for Tobrex is tobramycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Tobrex products the Orange Book lists.

What is the generic name for Tobrex?

The active ingredient in Tobrex is tobramycin, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

Generic for Tobrex