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APO-ZIDOVUDINE-LAMIVUDINE-NEVIRAPINE DIN 02281368

Status: Approved
Holder: APOTEX INC
Molecule: LAMIVUDINE

Health Canada record

Active ingredient(s)LAMIVUDINE 150 MG; NEVIRAPINE 200 MG; ZIDOVUDINE 300 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCJ05AR05 ZIDOVUDINE, LAMIVUDINE AND NEVIRAPINE
Original market date
Current status date30-May-2016
SourceHealth Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing LAMIVUDINE

DINProductCompanyFormStrengthStatus
021926913TCVIIV HEALTHCARE ULCSolutionLAMIVUDINE 10 MGMarketed
021926833TCVIIV HEALTHCARE ULCTabletLAMIVUDINE 150 MGMarketed
022478253TCVIIV HEALTHCARE ULCTabletLAMIVUDINE 300 MGMarketed
02369052APO-LAMIVUDINEAPOTEX INCTabletLAMIVUDINE 150 MGMarketed
02369060APO-LAMIVUDINEAPOTEX INCTabletLAMIVUDINE 300 MGMarketed
02393239APO-LAMIVUDINE HBVAPOTEX INCTabletLAMIVUDINE 100 MGMarketed
02375540APO-LAMIVUDINE-ZIDOVUDINEAPOTEX INCTabletLAMIVUDINE 150 MG; ZIDOVUDINE 300 MGMarketed
02414414AURO-LAMIVUDINE/ZIDOVUDINEAURO PHARMA INCTabletLAMIVUDINE 150 MG; ZIDOVUDINE 300 MGMarketed
02507129JAMP LAMIVUDINEJAMP PHARMA CORPORATIONTabletLAMIVUDINE 300 MGMarketed
02507110JAMP LAMIVUDINEJAMP PHARMA CORPORATIONTabletLAMIVUDINE 150 MGMarketed
02502801JAMP LAMIVUDINE / ZIDOVUDINEJAMP PHARMA CORPORATIONTabletLAMIVUDINE 150 MG; ZIDOVUDINE 300 MGMarketed
02512467JAMP LAMIVUDINE HBVJAMP PHARMA CORPORATIONTabletLAMIVUDINE 100 MGMarketed
02282216LAMIVUDINE ORAL SOLUTIONAUROBINDO PHARMA LIMITED (UNIT III)SolutionLAMIVUDINE 10 MGApproved
02410575AURO-LAMIVUDINEAURO PHARMA INCTabletLAMIVUDINE 150 MGCancelled Post Market
02410567AURO-LAMIVUDINEAURO PHARMA INCTabletLAMIVUDINE 300 MGCancelled Post Market
02239213COMBIVIRVIIV HEALTHCARE ULCTabletLAMIVUDINE 150 MG; ZIDOVUDINE 300 MGCancelled Post Market
02239193HEPTOVIRGLAXOSMITHKLINE INCTabletLAMIVUDINE 100 MGCancelled Post Market
02239194HEPTOVIRGLAXOSMITHKLINE INCSolutionLAMIVUDINE 5 MGCancelled Post Market
02387247TEVA-LAMIVUDINE/ZIDOVUDINETEVA CANADA LIMITEDTabletLAMIVUDINE 150 MG; ZIDOVUDINE 300 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
181462016-05-30Supplement to a New Drug Submission (SNDS)UPDATES TO THE PRODUCT MONOGRAPH AND CPID. CHANGE IN BRAND NAME
181562016-05-30New Drug Submission (NDS)

International API supply for LAMIVUDINE

8 valid EDQM Certificates of Suitability from 8 holders. 24 active FDA Drug Master Files.

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