Assyro AI

FDA Orange Book · active-ingredient family

Amoxicillin

Amoxicillin is approved as 7 brand and 62 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MOXATAG · NDA 050813

7

Brand (NDA)

62

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, for suspension, tablet, tablet, chewable, tablet, extended release, tablet, for suspension

ProductApplicantApplicationTEApproved
MOXATAGRLDPRAGMANDA 050813—Jan 23, 2008
AMOXILRLD×2US ANTIBIOTICSNDA 050760—Apr 15, 1999
AMOXILRLD×2US ANTIBIOTICSNDA 050754—Jul 10, 1998
AMOXILRLD×2GLAXOSMITHKLINENDA 050459—Approved Prior to Jan 1, 1982
AMOXILRLD×4GLAXOSMITHKLINENDA 050460—Approved Prior to Jan 1, 1982
AMOXILRLD×2US ANTIBIOTICSNDA 050542—Approved Prior to Jan 1, 1982
AMOXIL×2US ANTIBIOTICSNDA 050761—Apr 15, 1999

Generic (ANDA) products (62)

ProductApplicantApplicationTEApproved
AMOXICILLIN×2MICRO LABSANDA 207471ABJun 24, 2022
AMOXICILLIN×2HIKMAANDA 205274—Jun 25, 2020
AMOXICILLIN×2AUROBINDO PHARMA LTDANDA 204030ABSep 15, 2014
AMOXICILLINCHARTWELL RXANDA 065344—Jan 15, 2009
AMOXICILLINCHARTWELL RXANDA 065319ABJun 18, 2007
AMOXICILLIN×2SANDOZANDA 065387ABMar 26, 2007
AMOXICILLIN×2SANDOZANDA 065378ABMar 26, 2007
AMOXICILLIN×2HIKMA PHARMSANDA 065291ABFeb 05, 2007
AMOXICILLIN×2AUROBINDO PHARMA LTDANDA 065324—Jan 17, 2007
AMOXICILLIN×2AUROBINDOANDA 065334ABDec 28, 2006
AMOXICILLIN×2HIKMAANDA 065322ABJun 19, 2006
AMOXICILLIN×2HIKMAANDA 065325ABJun 19, 2006
AMOXICILLINHIKMAANDA 065255ABMar 29, 2006
AMOXICILLIN×2AUROBINDOANDA 065271ABNov 09, 2005
AMOXICILLIN×2AUROBINDOANDA 065256ABNov 09, 2005
AMOXICILLIN×2SANDOZANDA 065228ABJul 13, 2005
DISPERMOXRANBAXY LABS LTDANDA 065159—Dec 04, 2003
DISPERMOX×2RANBAXY LABS LTDANDA 065080—Aug 11, 2003
AMOXICILLIN×2TEVAANDA 065119ABDec 04, 2002
AMOXICILLIN×2SUN PHARM INDS LTDANDA 065113—Nov 29, 2002
AMOXICILLIN×2SUN PHARM INDS LTDANDA 065060—Nov 29, 2000
AMOXICILLIN×2SUN PHARM INDS LTDANDA 065059—Nov 24, 2000
AMOXICILLIN×2TEVAANDA 065056ABSep 18, 2000
AMOXICILLIN×2SUN PHARM INDS LTDANDA 065021—Dec 23, 1999
AMOXICILLIN×2SUN PHARM INDS LTDANDA 065016—Apr 08, 1999
AMOXICILLIN×2TEVAANDA 064031—Dec 19, 1996
AMOXICILLIN×2APOTHECONANDA 064131—May 06, 1996
AMOXICILLIN×2CHARTWELL RXANDA 064139—Jan 29, 1996
AMOXICILLIN×2TEVAANDA 064013—Sep 11, 1995
AMOXICILLIN×2SANDOZANDA 064076ABSep 30, 1994
TRIMOX×2APOTHECONANDA 063099—Mar 20, 1992
AMOXICILLINTEVAANDA 063030—Feb 28, 1989
AMOXICILLINTEVAANDA 063031—Feb 28, 1989
AMOXICILLINTEVAANDA 063001—Jan 06, 1989
AMOXICILLIN×2PH HEALTHANDA 062927—Nov 25, 1988
AMOXICILLINTEVAANDA 062946—Nov 01, 1988
TRIMOX×2APOTHECONANDA 062885—Mar 08, 1988
AMOXICILLINSTRIDES PHARMA INTLANDA 062884—Feb 25, 1988
AMOXICILLINSTRIDES PHARMA INTLANDA 062881—Feb 25, 1988
AMOXICILLINTEVAANDA 062853—Dec 22, 1987
AMOXICILLINTEVAANDA 062854—Dec 22, 1987
AMOXICILLIN×2LABS ATRALANDA 062528—Aug 07, 1985
AMOXICILLIN×2CHARTWELLANDA 062058ABApproved Prior to Jan 1, 1982
AMOXICILLIN×2MYLANANDA 062067—Approved Prior to Jan 1, 1982
AMOXICILLIN×2TEVAANDA 061926ABApproved Prior to Jan 1, 1982
AMOXIL×2US ANTIBIOTICSANDA 062216ABApproved Prior to Jan 1, 1982
TRIMOX×2APOTHECONANDA 061885—Approved Prior to Jan 1, 1982
TRIMOX×2APOTHECONANDA 062098—Approved Prior to Jan 1, 1982
TRIMOX×2APOTHECONANDA 062152—Approved Prior to Jan 1, 1982
UTIMOX×2PARKE DAVISANDA 062107—Approved Prior to Jan 1, 1982
WYMOX×2WYETH AYERSTANDA 062120—Approved Prior to Jan 1, 1982
AMOXICILLIN×2CHARTWELL RXANDA 062059—Approved Prior to Jan 1, 1982
AMOXICILLIN×2MYLANANDA 062090—Approved Prior to Jan 1, 1982
AMOXICILLIN×3TEVAANDA 061931—Approved Prior to Jan 1, 1982
AMOXIL×5US ANTIBIOTICSANDA 062226ABApproved Prior to Jan 1, 1982
POLYMOX×2APOTHECONANDA 061851—Approved Prior to Jan 1, 1982
POLYMOX×2APOTHECONANDA 062323—Approved Prior to Jan 1, 1982
TRIMOX×3APOTHECONANDA 061886—Approved Prior to Jan 1, 1982
TRIMOX×2APOTHECONANDA 062099—Approved Prior to Jan 1, 1982
TRIMOX×2APOTHECONANDA 062154—Approved Prior to Jan 1, 1982
UTIMOX×2PARKE DAVISANDA 062127—Approved Prior to Jan 1, 1982
WYMOX×2WYETH AYERSTANDA 062131—Approved Prior to Jan 1, 1982

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8778924Dec 08, 2026in 6 mo
SubstanceProductU-897
8357394Dec 08, 2026in 6 mo
Product
8299052May 07, 2027in 11 mo
U-1304

Amoxicillin — frequently asked questions

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

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