Assyro AI

FDA Orange Book · active-ingredient family

Terbutaline sulfate

Terbutaline sulfate is approved as 6 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BRETHINE · NDA 018571

6

Brand (NDA)

9

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered, injectable, tablet

ProductApplicantApplicationTEApproved
BRETHINERLDPHARMACARENDA 018571—Approved Prior to Jan 1, 1982
BRETHINERLD×2ANI PHARMSNDA 017849ABApproved Prior to Jan 1, 1982
BRICANYLSANOFI AVENTIS USNDA 018000—Mar 19, 1985
BRETHAIRENOVARTISNDA 018762—Aug 17, 1984
BRICANYLSANOFI AVENTIS USNDA 017466—Approved Prior to Jan 1, 1982
BRICANYL×2SANOFI AVENTIS USNDA 017618—Approved Prior to Jan 1, 1982

Generic (ANDA) products (9)

ProductApplicantApplicationTEApproved
TERBUTALINE SULFATE×2TWI PHARMSANDA 211832ABJun 19, 2020
TERBUTALINE SULFATEAREVA PHARMSANDA 200122APNov 08, 2013
TERBUTALINE SULFATEHIKMA FARMACEUTICAANDA 078630APMay 20, 2009
TERBUTALINE SULFATEEPIC PHARMA LLCANDA 078151—Jan 07, 2008
TERBUTALINE SULFATE×2LANNETT CO INCANDA 077152ABMar 25, 2005
TERBUTALINE SULFATEDR REDDYSANDA 076853—Jul 20, 2004
TERBUTALINE SULFATEFRESENIUS KABI USAANDA 076887APMay 26, 2004
TERBUTALINE SULFATECHARTWELL INJECTABLEANDA 076770—Apr 23, 2004
TERBUTALINE SULFATE×2IMPAX LABSANDA 075877ABJun 26, 2001

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Terbutaline sulfate — 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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