Assyro AI

FDA Orange Book · active-ingredient family

Phendimetrazine tartrate

Phendimetrazine tartrate is approved as 2 brand and 94 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PHENDIMETRAZINE TARTRATE · NDA 018074

2

Brand (NDA)

94

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, extended release, tablet

ProductApplicantApplicationTEApproved
PHENDIMETRAZINE TARTRATERLDACERTIS PHARMSNDA 018074—Approved Prior to Jan 1, 1982
PLEGINEWYETH AYERSTNDA 012248—Approved Prior to Jan 1, 1982

Generic (ANDA) products (94)

ProductApplicantApplicationTEApproved
PHENDIMETRAZINE TARTRATEMPP PHARMAANDA 203600—Dec 27, 2017
PHENDIMETRAZINE TARTRATEKVK TECHANDA 091042AAAug 31, 2010
PHENDIMETRAZINE TARTRATEELITE LABS INCANDA 040762AAJan 28, 2008
PHENDIMETRAZINE TARTRATECHARTWELLANDA 089452AAOct 30, 1991
PHENDIMETRAZINE TARTRATEFERNDALE LABSANDA 086834—Sep 15, 1983
PHENDIMETRAZINE TARTRATECHARTWELL RXANDA 085941—Jun 27, 1983
SPRX-105NUMARKANDA 088024—Dec 22, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 088111—Oct 18, 1982
MELFIAT-105NUMARKANDA 087487—Oct 13, 1982
X-TROZINESHIRE RICHWOODANDA 087394—Sep 22, 1982
BONTRILVALEANTANDA 088021—Sep 21, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 088062—Sep 13, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 088063—Sep 10, 1982
X-TROZINE L.A.SHIRE RICHWOODANDA 087371—Aug 24, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 088020—Aug 16, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 088028—Aug 16, 1982
PHENDIMETRAZINE TARTRATEGRAHAM DMANDA 087214—May 26, 1982
PHENDIMETRAZINE TARTRATEVIRTUSANDA 087378—Approved Prior to Jan 1, 1982
PHENAZINEMAST MMANDA 086523—Approved Prior to Jan 1, 1982
PHENAZINEMAST MMANDA 086524—Approved Prior to Jan 1, 1982
PHENAZINEMAST MMANDA 086525—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 085633—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 085694—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 085702—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVIRTUSANDA 085695—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 085634—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 085645—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 085670—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 086403—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 086408—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 086410—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 087424—Approved Prior to Jan 1, 1982
SPRX-3SOLVAYANDA 085897—Approved Prior to Jan 1, 1982
STATOBEXTEVAANDA 085507—Approved Prior to Jan 1, 1982
ADPHENFERNDALE LABSANDA 083655—Approved Prior to Jan 1, 1982
ALPHAZINESANDOZANDA 085034—Approved Prior to Jan 1, 1982
BONTRIL PDMRLDBAUSCHANDA 085272AAApproved Prior to Jan 1, 1982
CAM-METRAZINEABC HOLDINGANDA 085511—Approved Prior to Jan 1, 1982
CAM-METRAZINECAMALLANDA 085756—Approved Prior to Jan 1, 1982
CAM-METRAZINECHARTWELL RXANDA 083922—Approved Prior to Jan 1, 1982
CAM-METRAZINECHARTWELL RXANDA 085318—Approved Prior to Jan 1, 1982
CAM-METRAZINECHARTWELL RXANDA 085320—Approved Prior to Jan 1, 1982
CAM-METRAZINECHARTWELL RXANDA 085321—Approved Prior to Jan 1, 1982
DI-METREXPVT FORMANDA 085698—Approved Prior to Jan 1, 1982
MELFIAT×2NUMARKANDA 083790—Approved Prior to Jan 1, 1982
METRAFOREST PHARMSANDA 083754—Approved Prior to Jan 1, 1982
PHENAZINEMAST MMANDA 087305—Approved Prior to Jan 1, 1982
PHENAZINE-35ABC HOLDINGANDA 085512—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEACERTIS PHARMSANDA 085588AAApproved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 083644—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 083684—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 083686—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 083687—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 084831—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 084834—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEBARRANDA 084835—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATECHARTWELL RXANDA 085761—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEINWOOD LABSANDA 084740—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEINWOOD LABSANDA 084741—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEINWOOD LABSANDA 084742—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEINWOOD LABSANDA 084743—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEIVAX PHARMSANDA 085611—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEIVAX PHARMSANDA 085612—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEIVAX SUB TEVA PHARMSANDA 083682—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEKV PHARMANDA 084138—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEKV PHARMANDA 084141—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEKV PHARMANDA 085525—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEMFG CHEMISTSANDA 085914—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATENEXGEN PHARMA INCANDA 086020—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEPVT FORMANDA 085199—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEPVT FORMANDA 085697—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 085402—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 085830—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESANDOZANDA 086370—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATESOLVAYANDA 083993—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEUPSHER SMITH LABSANDA 084399—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEUSL PHARMAANDA 083805—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEUSL PHARMAANDA 084398—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVIRTUSANDA 085497—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVIRTUSANDA 086365—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 085519—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 086005—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEVITARINEANDA 086106—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEWATSON LABSANDA 085767—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEWATSON LABSANDA 085768—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEWATSON LABSANDA 085770—Approved Prior to Jan 1, 1982
PHENDIMETRAZINE TARTRATEWATSON LABSANDA 085773—Approved Prior to Jan 1, 1982
STATOBEXTEVAANDA 086013—Approved Prior to Jan 1, 1982
STATOBEX-GTEVAANDA 085095—Approved Prior to Jan 1, 1982
X-TROZINESHIRE RICHWOODANDA 086550—Approved Prior to Jan 1, 1982
X-TROZINESHIRE RICHWOODANDA 086551—Approved Prior to Jan 1, 1982
X-TROZINESHIRE RICHWOODANDA 086552—Approved Prior to Jan 1, 1982
X-TROZINESHIRE RICHWOODANDA 086553—Approved Prior to Jan 1, 1982
X-TROZINESHIRE RICHWOODANDA 086554—Approved Prior to Jan 1, 1982

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.

Phendimetrazine tartrate — frequently asked questions

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

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