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ACTIVE SUBSTANCE / INN

STAVUDINE

Brand name(s): STAVUDINE; LAMIVUDINE W/NEVIRAPINE, LAMIVUDINE AND STAVUDINE, ZERIT, STAVUDINE; LAMIVUDINE; EFAVIRENZ, STAVUDINE; LAMIVUDINE, LAMIVUDINE; STAVUDINE, STAVUDINE; LAMIVUDINE; NEVIRAPINE, Zerit, STAVUDINE, LAMIVUDINE, NEVIRAPINE, AND STAVUDINE
FDA LISTED
EMA LISTED
WITHDRAWN
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA078256
NDA022479
ACTIVE SUBSTANCE
Stavudine
REGULATORS
FDA · EMA
SPONSORS / MAH
STRIDES ACROLAB, HETERO DRUGS LTD, BRISTOL
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
STAVUDINE; LAMIVUDINE W/NEVIRAPINENDA021854STRIDES ACROLABNone (Tentative Approval)
STAVUDINE; LAMIVUDINE; NEVIRAPINENDA022342EMCURE PHARMANone (Tentative Approval)
STAVUDINEANDA077774AUROBINDO PHARMADiscontinued
STAVUDINEANDA078256STRIDES ACROLABNone (Tentative Approval)
LAMIVUDINE; STAVUDINENDA022085MATRIX LABSNone (Tentative Approval)
STAVUDINE; LAMIVUDINENDA021838STRIDES ACROLABNone (Tentative Approval)
STAVUDINE; LAMIVUDINE; EFAVIRENZNDA022097STRIDES ACROLABNone (Tentative Approval)
LAMIVUDINE AND STAVUDINENDA022479HETERO DRUGS LTDNone (Tentative Approval)
ZERITNDA020413BRISTOLDiscontinued
LAMIVUDINE, NEVIRAPINE, AND STAVUDINENDA200244HETERO DRUGS LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZeritBristol-Myers Squibb Pharma EEIGWithdrawn08/05/1996HIV Infections

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