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ACTIVE SUBSTANCE / INN

ZOLEDRONIC ACID

Brand name(s): Zoledronic acid Teva Generics, Zoledronic Acid Hospira, ZOMETA, ZOLEDRONIC, Zoledronic acid Actavis, RECLAST, Zoledronic acid Mylan, Zoledronic Acid Accord, Zoledronic acid Teva, Zoledronic acid medac, Aclasta, Zometa, ZOLEDRONIC ACID, Zoledronic acid Teva Pharma
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA209125
Osteoporosis;Osteitis Deformans
ACTIVE SUBSTANCE
Zoledronic Acid
REGULATORS
FDA · EMA
SPONSORS / MAH
Sandoz Pharmaceuticals d.d., EUGIA PHARMA, Phoenix Labs Unlimited Company
TOTAL APPLICATIONS
17
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ZOLEDRONIC ACIDANDA091516FRESENIUS KABI USAPrescription
ZOLEDRONIC ACIDANDA203344PFIZER INCNone (Tentative Approval)
ZOLEDRONIC ACIDANDA209125EUGIA PHARMADiscontinued
RECLASTNDA022080SANDOZPrescription
ZOMETANDA021223NOVARTISDiscontinued
ZOLEDRONICANDA205749GLANDPrescription
ZOMETANDA021386NOVARTISPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Zoledronic Acid AccordAccord Healthcare S.L.U.Authorised16/01/2014Hypercalcemia;Fractures, Bone;Cancer
Zoledronic acid MylanMylan Pharmaceuticals LimitedAuthorised23/08/2012Fractures, Bone
Zoledronic acid TevaTeva B.V.Authorised16/08/2012Fractures, Bone;Cancer
ZometaPhoenix Labs Unlimited CompanyAuthorised20/03/2001Cancer;Fractures, Bone
AclastaSandoz Pharmaceuticals d.d.Authorised15/04/2005Osteoporosis;Osteitis Deformans;Osteoporosis, Postmenopausal
Zoledronic acid ActavisActavis Group PTC ehfAuthorised20/04/2012Fractures, Bone
Zoledronic Acid HospiraPfizer Europe MA EEIGAuthorised19/11/2012Hypercalcemia
Zoledronic acid medacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised03/08/2012Fractures, Bone;Cancer
Zoledronic acid Teva PharmaTeva B.V.Withdrawn15/08/2012Osteoporosis;Osteitis Deformans;Osteoporosis, Postmenopausal
Zoledronic acid Teva GenericsTeva Generics B.VWithdrawn27/03/2014Osteoporosis;Osteitis Deformans

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