Assyro AI

FDA Orange Book · active-ingredient family

Phentermine hydrochloride

Phentermine hydrochloride is approved as 3 brand and 96 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:WILPO · NDA 012737

3

Brand (NDA)

96

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
WILPORLDSANDOZNDA 012737—Approved Prior to Jan 1, 1982
SUPRENZA×3CITIUS PHARMSNDA 202088—Jun 13, 2011
FASTINGLAXOSMITHKLINENDA 017352—Approved Prior to Jan 1, 1982

Generic (ANDA) products (96)

ProductApplicantApplicationTEApproved
PHENTERMINE HYDROCHLORIDE×3ZYDUS PHARMSANDA 204663—Jun 28, 2017
PHENTERMINE HYDROCHLORIDEKVK TECH INCANDA 203436AAMar 17, 2017
PHENTERMINE HYDROCHLORIDEPURACAP LABS BLUANDA 206342AANov 18, 2016
PHENTERMINE HYDROCHLORIDE×2AUROLIFE PHARMA LLCANDA 204318AANov 09, 2016
LOMAIRAAVANTHI INCANDA 203495AASep 12, 2016
PHENTERMINE HYDROCHLORIDE×2NUVO PHARMANDA 205019AADec 05, 2014
PHENTERMINE HYDROCHLORIDENUVO PHARMANDA 205017AASep 25, 2014
PHENTERMINE HYDROCHLORIDENUVO PHARMANDA 205008AASep 25, 2014
PHENTERMINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 203068AAAug 06, 2014
PHENTERMINE HYDROCHLORIDEINVAGEN PHARMSANDA 204414—May 05, 2014
PHENTERMINE HYDROCHLORIDE×2INVAGEN PHARMSANDA 202858—Feb 14, 2014
PHENTERMINE HYDROCHLORIDEINVAGEN PHARMSANDA 202846—Feb 05, 2014
PHENTERMINE HYDROCHLORIDEINVAGEN PHARMSANDA 202942—Feb 05, 2014
PHENTERMINE HYDROCHLORIDE×2ELITE LABSANDA 202248AASep 28, 2012
PHENTERMINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 091451—Sep 21, 2012
PHENTERMINE HYDROCHLORIDE×2LANNETTANDA 087022—Jan 20, 2012
PHENTERMINE HYDROCHLORIDELANNETT CO INCANDA 201961—Jul 20, 2011
PHENTERMINE HYDROCHLORIDEELITE LABSANDA 200272AAJan 31, 2011
PHENTERMINE HYDROCHLORIDELANNETT CO INCANDA 091359—Jul 16, 2010
PHENTERMINE HYDROCHLORIDE×2BARRANDA 090591—Mar 18, 2010
PHENTERMINE HYDROCHLORIDEBARRANDA 090470—Aug 31, 2009
PHENTERMINE HYDROCHLORIDEKVK TECHANDA 040887AAApr 24, 2008
PHENTERMINE HYDROCHLORIDE×2KVK TECHANDA 040886AAMar 31, 2008
PHENTERMINE HYDROCHLORIDEKVK TECHANDA 040876AAMar 31, 2008
PHENTERMINE HYDROCHLORIDEKVK TECHANDA 040875AAMar 21, 2008
PHENTERMINE HYDROCHLORIDESUN PHARM INDS INCANDA 040790—Aug 21, 2007
PHENTERMINE HYDROCHLORIDELANNETTANDA 040555—Apr 15, 2005
PHENTERMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 040525—Oct 23, 2003
PHENTERMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 040527—Oct 23, 2003
PHENTERMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 040526AAOct 23, 2003
PHENTERMINE HYDROCHLORIDEABLEANDA 040497—Mar 13, 2003
PHENTERMINE HYDROCHLORIDEELITE LABS INCANDA 040448—Jan 22, 2003
PHENTERMINE HYDROCHLORIDEELITE LABS INCANDA 040460—Jan 14, 2003
PHENTERMINE HYDROCHLORIDEPRINSTON INCANDA 040377AAJan 04, 2002
PHENTERMINE HYDROCHLORIDEABLEANDA 040403—Aug 30, 2001
PHENTERMINE HYDROCHLORIDEABLEANDA 040427—Aug 30, 2001
PHENTERMINE HYDROCHLORIDEABLEANDA 040402—Aug 30, 2001
PHENTERMINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 040276—Nov 25, 1998
PHENTERMINE HYDROCHLORIDEELITE LABS INCANDA 040228—Jun 19, 1997
PHENTERMINE HYDROCHLORIDEELITE LABS INCANDA 040227—Jun 18, 1997
PHENTERMINE HYDROCHLORIDEELITE LABS INCANDA 040190AAMay 30, 1997
PHENTERMINE HYDROCHLORIDETG UNITED INCANDA 040083—Mar 07, 1997
PHENTERMINE HYDROCHLORIDESANDOZ INCANDA 088605—Sep 28, 1987
PHENTERMINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 088948—Apr 25, 1986
PHENTERMINE HYDROCHLORIDETEVAANDA 087777—Nov 01, 1985
PHENTERMINE HYDROCHLORIDEUSL PHARMAANDA 088910—Jul 17, 1985
PHENTERMINE HYDROCHLORIDEUSL PHARMAANDA 088917—Jul 17, 1985
PHENTERMINE HYDROCHLORIDEWATSON LABSANDA 086740—Mar 21, 1985
PHENTERMINE HYDROCHLORIDEUSL PHARMAANDA 088797—Dec 10, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 088625—Aug 23, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 088610—Jun 04, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 088611—Jun 04, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 088576—May 23, 1984
PHENTERMINE HYDROCHLORIDETEVAANDA 088613—Apr 09, 1984
PHENTERMINE HYDROCHLORIDETEVAANDA 088614—Apr 09, 1984
PHENTERMINE HYDROCHLORIDETEVAANDA 088612—Apr 04, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 088596—Apr 04, 1984
PHENTERMINE HYDROCHLORIDEUPSHER SMITH LABSANDA 088430—Mar 27, 1984
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 087915—Dec 22, 1983
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 087918—Dec 22, 1983
PHENTERMINE HYDROCHLORIDESANDOZANDA 088414—Oct 19, 1983
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 087930—Oct 14, 1983
ADIPEX-PRLDTEVAANDA 088023—Aug 02, 1983
PHENTERMINE HYDROCHLORIDERLDSANDOZANDA 086945AAJul 20, 1983
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 087805—Dec 06, 1982
PHENTERMINE HYDROCHLORIDEUPSHER SMITH LABSANDA 084487—Apr 09, 1982
OBY-TRIMSHIRE RICHWOODANDA 087764—Mar 18, 1982
OBESTIN-30FERNDALE LABSANDA 087144—Approved Prior to Jan 1, 1982
ONA-MASTMAST MMANDA 086511—Approved Prior to Jan 1, 1982
ONA-MASTMAST MMANDA 086516—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEABC HOLDINGANDA 085411—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECAMALLANDA 086735—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECAMALLANDA 087226—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 085417—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 086732—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 087215—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEIVAX PHARMSANDA 086329—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDERLD×2SANDOZANDA 087190AAApproved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDESANDOZANDA 087208—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDESANDOZANDA 087223—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDETEVAANDA 086911—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDETEVAANDA 087126—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEVITARINEANDA 087202—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEVITARINEANDA 087235—Approved Prior to Jan 1, 1982
ADIPEX-PRLDTEVAANDA 085128AAApproved Prior to Jan 1, 1982
ONA-MASTMAST MMANDA 086260—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 083923—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDECHARTWELL RXANDA 085319—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEIVAX PHARMSANDA 085553—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDESANDOZANDA 085671—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDESANDOZANDA 085689—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDERLDUSL PHARMAANDA 083804—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEVITARINEANDA 086453—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEVITARINEANDA 086456—Approved Prior to Jan 1, 1982
PHENTERMINE HYDROCHLORIDEWATSON LABSANDA 085739—Approved Prior to Jan 1, 1982
TORASOLVAYANDA 084035—Approved Prior to Jan 1, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8440170Mar 14, 2029in 2 yr 9 mo
Product

Phentermine hydrochloride — frequently asked questions

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

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