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FDA Orange Book · active-ingredient family

Atracurium besylate

Atracurium besylate is approved as 1 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRACRIUM · NDA 018831

1

Brand (NDA)

22

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
TRACRIUMRLD×2HOSPIRANDA 018831—Jun 20, 1985

Generic (ANDA) products (22)

ProductApplicantApplicationTEApproved
ATRACURIUM BESYLATEPHARMOBEDIENTANDA 206096—Jun 22, 2017
ATRACURIUM BESYLATE PRESERVATIVE FREEPHARMOBEDIENTANDA 206001—Apr 07, 2017
ATRACURIUM BESYLATEEUGIA PHARMAANDA 206011—Apr 08, 2015
ATRACURIUM BESYLATE PRESERVATIVE FREEEUGIA PHARMAANDA 206010—Apr 08, 2015
ATRACURIUM BESYLATEHOSPIRA INCANDA 090761APOct 18, 2012
ATRACURIUM BESYLATE PRESERVATIVE FREEHOSPIRA INCANDA 090782APOct 18, 2012
ATRACURIUM BESYLATEMEITHEALANDA 091489APFeb 17, 2012
ATRACURIUM BESYLATE PRESERVATIVE FREEMEITHEALANDA 091488APFeb 17, 2012
ATRACURIUM BESYLATEWATSON PHARMS TEVAANDA 074945—Jul 28, 1998
ATRACURIUM BESYLATE PRESERVATIVE FREEWATSON LABS INCANDA 074944—Jul 28, 1998
ATRACURIUM BESYLATEBAXTER HLTHCAREANDA 074824—Sep 30, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREEBAXTER HLTHCAREANDA 074825—Sep 30, 1997
ATRACURIUM BESYLATEHIKMAANDA 074901APJul 18, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREEHIKMAANDA 074900APJul 18, 1997
ATRACURIUM BESYLATETEVA PARENTERALANDA 074784—Jun 11, 1997
ATRACURIUM BESYLATEHOSPIRAANDA 074740—Mar 28, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREEHOSPIRAANDA 074741—Mar 28, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREEHOSPIRAANDA 074639—Mar 25, 1997
ATRACURIUM BESYLATEBAXTER HLTHCARE CORPANDA 074753—Jan 23, 1997
ATRACURIUM BESYLATE PRESERVATIVE FREEBAXTER HLTHCARE CORPANDA 074768—Jan 23, 1997
ATRACURIUM BESYLATEHOSPIRAANDA 074632—Dec 23, 1996
ATRACURIUM BESYLATE PRESERVATIVE FREEHOSPIRAANDA 074633—Dec 23, 1996

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.

Atracurium besylate — frequently asked questions

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

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