Assyro AI

FDA Orange Book · active-ingredient family

Amiodarone hydrochloride

Amiodarone hydrochloride is approved as 4 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NEXTERONE · NDA 022325

4

Brand (NDA)

31

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
NEXTERONERLD×3BAXTER HLTHCARENDA 022325—Dec 24, 2008
CORDARONERLDWYETH PHARMS INCNDA 020377—Aug 03, 1995
CORDARONERLDWYETH PHARMSNDA 018972—Dec 24, 1985
AMIODARONE HYDROCHLORIDEINTL MEDICATION SYSNDA 021594—Feb 04, 2004

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
AMIODARONE HYDROCHLORIDEZHEJIANG POLY PHARMANDA 218253APSep 11, 2024
AMIODARONE HYDROCHLORIDE×3ZYDUS PHARMS USA INCANDA 079029ABJan 06, 2023
AMIODARONE HYDROCHLORIDE×3RUBICON RESEARCHANDA 078578ABFeb 26, 2021
AMIODARONE HYDROCHLORIDEUNICHEMANDA 213446ABJul 21, 2020
AMIODARONE HYDROCHLORIDE×3DR REDDYS LABS SAANDA 075389ABDec 28, 2017
AMIODARONE HYDROCHLORIDEEUGIA PHARMAANDA 204550—Oct 25, 2017
AMIODARONE HYDROCHLORIDE×3CHARTWELL RXANDA 077069ABOct 04, 2016
AMIODARONE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 204742ABJun 03, 2016
AMIODARONE HYDROCHLORIDEHOSPIRAANDA 203884—Nov 25, 2013
AMIODARONE HYDROCHLORIDEHOSPIRAANDA 203885—Nov 25, 2013
AMIODARONE HYDROCHLORIDEACELLAANDA 077610APOct 30, 2008
AMIODARONE HYDROCHLORIDEACELLAANDA 077834APOct 30, 2008
AMIODARONE HYDROCHLORIDEHIKMA FARMACEUTICAANDA 077234APFeb 25, 2008
AMIODARONE HYDROCHLORIDEEPIC PHARMA LLCANDA 076232—Jul 05, 2006
AMIODARONE HYDROCHLORIDEGLAND PHARMA LTDANDA 077161APApr 20, 2005
PACERONE×3UPSHER SMITH LABSANDA 075135ABApr 12, 2005
AMIODARONE HYDROCHLORIDE×2TAROANDA 076362—Dec 02, 2003
AMIODARONE HYDROCHLORIDEDR REDDYSANDA 076163—Sep 05, 2003
AMIODARONE HYDROCHLORIDEPAR STERILE PRODUCTSANDA 076394—Apr 25, 2003
AMIODARONE HYDROCHLORIDE×2TAROANDA 075424ABDec 18, 2002
AMIODARONE HYDROCHLORIDEBEDFORD LABSANDA 076299—Oct 24, 2002
AMIODARONE HYDROCHLORIDEHOSPIRAANDA 075955—Oct 18, 2002
AMIODARONE HYDROCHLORIDEBEDFORDANDA 076018—Oct 15, 2002
AMIODARONE HYDROCHLORIDEBEN VENUEANDA 076088—Oct 15, 2002
AMIODARONE HYDROCHLORIDEFRESENIUS KABI USAANDA 075761APOct 15, 2002
AMIODARONE HYDROCHLORIDEHOSPIRAANDA 076108—Oct 15, 2002
AMIODARONE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 076217APOct 15, 2002
AMIODARONE HYDROCHLORIDETEVAANDA 074895—Apr 16, 1999
AMIODARONE HYDROCHLORIDEPHARMOBEDIENTANDA 075188—Feb 24, 1999
AMIODARONE HYDROCHLORIDE×2UPSHER SMITH LABSANDA 075315—Dec 23, 1998
AMIODARONE HYDROCHLORIDETEVA PHARMSANDA 074739ABNov 30, 1998

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7635773Mar 13, 2029in 2 yr 9 mo
Product
8410077Mar 13, 2029in 2 yr 9 mo
Product
10117951Mar 13, 2029in 2 yr 9 mo
Product
10177951Mar 13, 2029in 2 yr 9 mo
Product
9200088Mar 13, 2029in 2 yr 9 mo
Product
9750822Mar 13, 2029in 2 yr 9 mo
Product
9493582Feb 27, 2033in 6 yr 10 mo
Product

Amiodarone hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo