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FDA Orange Book · active-ingredient family

Tobramycin

Tobramycin is approved as 6 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOBI PODHALER · NDA 201688

6

Brand (NDA)

22

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · ointment, powder, solution, solution/drops

ProductApplicantApplicationTEApproved
TOBI PODHALERRLDVIATRISNDA 201688—Mar 22, 2013
BETHKISRLDCHIESINDA 201820ANOct 12, 2012
TOBIRLDVIATRISNDA 050753ANDec 22, 1997
TOBREXRLDNOVARTISNDA 050555—Approved Prior to Jan 1, 1982
TOBREXRLDNOVARTISNDA 050541—Approved Prior to Jan 1, 1982
KITABIS PAKPULMOFLOW INCNDA 205433ANDec 02, 2014

Generic (ANDA) products (22)

ProductApplicantApplicationTEApproved
TOBRAMYCINMICRO LABSANDA 217344ANJul 27, 2023
TOBRAMYCINMANKIND PHARMAANDA 214478ANJun 30, 2023
TOBRAMYCINMANKIND PHARMAANDA 216725ANSep 22, 2022
TOBRAMYCINALKEM LABS LTDANDA 212848ANApr 01, 2021
TOBRAMYCINGLANDANDA 212628ATMar 09, 2021
TOBRAMYCINLUOXIN AUROVITASANDA 210871—Jan 22, 2021
TOBRAMYCINSUN PHARMANDA 207136ANDec 26, 2019
TOBRAMYCINTEVA PHARMS USAANDA 210915ANJun 26, 2019
TOBRAMYCINALEMBICANDA 211847ATApr 19, 2019
TOBRAMYCINDR REDDYS LABS SAANDA 207080ANJul 09, 2018
TOBRAMYCINPHARMOBEDIENTANDA 209554—Oct 13, 2017
TOBRAMYCINSOMERSET THERAPS LLCANDA 207444ATJun 28, 2017
TOBRAMYCINLUPINANDA 208964ANMar 22, 2017
TOBRAMYCINAMNEAL PHARMSANDA 205501ANJul 13, 2015
TOBRAMYCINHIKMAANDA 201422ANMay 28, 2014
TOBRAMYCINTEVA PHARMS USAANDA 091589ANOct 10, 2013
TOBRAMYCINAPOTEX INCANDA 065087—Feb 25, 2002
TOBRAMYCINCHARTWELL RXANDA 065026ATSep 11, 2001
AKTOBEPIC PHARMA LLCANDA 064096—Jan 31, 1996
TOBRAMYCINALCON PHARMS LTDANDA 063176—May 25, 1994
TOBRAMYCINBAUSCH AND LOMB INCANDA 064052ATNov 29, 1993
TOBREXSANDOZANDA 062535ATDec 13, 1984

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8869794Sep 12, 2028in 2 yr 3 mo
ProductU-909
10207066Nov 04, 2030in 4 yr 5 mo
ProductU-909

Tobramycin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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