FDA Orange Book

Generic for Kitabis Pak

Kitabis Pak contains tobramycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Kitabis Pak is tobramycin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.

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Kitabis Pak products in the Orange Book

Kitabis Pak products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, inhalation	300MG/5ML	Marketed (Rx)	AN	9	AN

NDA 205433, held by PULMOFLOW INC. 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 Kitabis Pak
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA	091589	AN (A-rated, therapeutically equivalent)	October 10, 2013	300MG/5ML
HIKMA PHARMACEUTICALS USA INC	201422	AN (A-rated, therapeutically equivalent)	May 28, 2014	300MG/5ML
AMNEAL PHARMACEUTICALS OF NEW YORK LLC	205501	AN (A-rated, therapeutically equivalent)	July 13, 2015	300MG/5ML
LUPIN INC	208964	AN (A-rated, therapeutically equivalent)	March 22, 2017	300MG/5ML
DR REDDYS LABORATORIES SA	207080	AN (A-rated, therapeutically equivalent)	July 9, 2018	300MG/5ML
SUN PHARMACEUTICAL INDUSTRIES LTD	207136	AN (A-rated, therapeutically equivalent)	December 26, 2019	300MG/5ML
ALKEM LABORATORIES LTD	212848	AN (A-rated, therapeutically equivalent)	April 1, 2021	300MG/5ML
MANKIND PHARMA LTD	214478	AN (A-rated, therapeutically equivalent)	June 30, 2023	300MG/5ML
MICRO LABS LTD	217344	AN (A-rated, therapeutically equivalent)	July 27, 2023	300MG/5ML

Kitabis Pak NDC codes

Questions

Is there a generic for Kitabis Pak?

Yes. The generic name for Kitabis Pak is tobramycin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.

What is the generic name for Kitabis Pak?

The active ingredient in Kitabis Pak 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.