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ACTIVE SUBSTANCE / INN

ABACAVIR

Brand name(s): LAMIVUDINE; ZIDOVUDINE; ABACAVIR, Ziagen, EPZICOM, ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE, ABACAVIR; LAMIVUDINE, ABACAVIR AND LAMIVUDINE
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA204004
HIV Infections
ACTIVE SUBSTANCE
Abacavir
REGULATORS
FDA · EMA
SPONSORS / MAH
LAURUS LABS LTD, AUROBINDO PHARMA LTD, ViiV Healthcare B.V.
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ABACAVIR AND LAMIVUDINENDA208775CIPLA LIMITEDNone (Tentative Approval)
LAMIVUDINE; ZIDOVUDINE; ABACAVIRNDA021944AUROBINDO PHARMA LTDNone (Tentative Approval)
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINEANDA216223LAURUS LABS LTDNone (Tentative Approval)
EPZICOMANDA204004MYLAN PHARMS INCNone (Tentative Approval)
ABACAVIR; LAMIVUDINENDA207369HETERO LABS LTD VNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZiagenViiV Healthcare B.V.Authorised08/07/1999HIV Infections

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