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ACTIVE SUBSTANCE / INN

TERIPARATIDE

Brand name(s): Teriparatide Ascend, Qutavina, Zandoriah, TERIPARATIDE, Terrosa, BONSITY, Movymia, Teriparatide Sun, Forsteo, Sondelbay, Teriparatide Cinnagen, Livogiva, FORTEO, Kauliv
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption
NDA021318
ACTIVE SUBSTANCE
Teriparatide
REGULATORS
FDA · EMA
SPONSORS / MAH
Strides Pharma (Cyprus) Limited, CinnaGen Co Unipessoal LDA, Gedeon Richter Plc.
TOTAL APPLICATIONS
16
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TERIPARATIDEANDA211097APOTEXPrescription
FORTEONDA021318LILLYPrescription
FORTEONDA021318LILLYDiscontinued
BONSITYNDA211939ALVOGENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZandoriahCinnaGen Co Unipessoal LDAOpinionOsteoporosis;Osteoporosis, Postmenopausal
MovymiaSTADA Arzneimittel AGAuthorised11/01/2017Osteoporosis
ForsteoEli Lilly Nederland B.V.Authorised10/06/2003Osteoporosis;Osteoporosis, Postmenopausal
TerrosaGedeon Richter Plc.Authorised04/01/2017Osteoporosis
LivogivaTheramex Ireland LimitedAuthorised27/08/2020Osteoporosis
Teriparatide SunSun Pharmaceutical Industries Europe B.V.Authorised18/11/2022Osteoporosis;Osteoporosis, Postmenopausal
SondelbayAccord Healthcare S.L.U.Authorised24/03/2022Osteoporosis
Teriparatide AscendAscend GmbHApplication withdrawnOsteoporosis;Osteoporosis, Postmenopausal;Bone Resorption
KaulivStrides Pharma (Cyprus) LimitedAuthorised12/01/2023Osteoporosis;Osteoporosis, Postmenopausal
Teriparatide CinnagenCinnaGen Co Unipessoal LDAApplication withdrawnOsteoporosis;Osteoporosis, Postmenopausal

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