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ACYCLOVIR DIN 02197421

Status: Approved
Holder: APOTEX INC
Molecule: ACYCLOVIR

Health Canada record

Active ingredient(s)ACYCLOVIR 800 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCJ05AB01 ACYCLOVIR
Original market date31-Dec-1996
Current status date12-Feb-2021
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 ACYCLOVIR

DINProductCompanyFormStrengthStatus
02197405ACYCLOVIRAPOTEX INCTabletACYCLOVIR 200 MGApproved
02197413ACYCLOVIRAPOTEX INCTabletACYCLOVIR 400 MGApproved
02207621APO-ACYCLOVIRAPOTEX INCTabletACYCLOVIR 200 MGMarketed
02207656APO-ACYCLOVIRAPOTEX INCTabletACYCLOVIR 800 MGMarketed
02207648APO-ACYCLOVIRAPOTEX INCTabletACYCLOVIR 400 MGMarketed
02477130APO-ACYCLOVIR OINTMENTAPOTEX INCOintmentACYCLOVIR 5 %Marketed
02524724MINT-ACYCLOVIRMINT PHARMACEUTICALS INCTabletACYCLOVIR 800 MGMarketed
02524716MINT-ACYCLOVIRMINT PHARMACEUTICALS INCTabletACYCLOVIR 400 MGMarketed
02524708MINT-ACYCLOVIRMINT PHARMACEUTICALS INCTabletACYCLOVIR 200 MGMarketed
02560437MINT-ACYCLOVIR OINTMENTMINT PHARMACEUTICALS INCOintmentACYCLOVIR 5 %Approved
02242464MYLAN-ACYCLOVIRMYLAN PHARMACEUTICALS ULCTabletACYCLOVIR 800 MGMarketed
02242463MYLAN-ACYCLOVIRMYLAN PHARMACEUTICALS ULCTabletACYCLOVIR 400 MGMarketed
02242784MYLAN-ACYCLOVIRMYLAN PHARMACEUTICALS ULCTabletACYCLOVIR 200 MGMarketed
02522306TARO-ACYCLOVIRTARO PHARMACEUTICALS INCOintmentACYCLOVIR 5 %Marketed
02285967TEVA-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 400 MGMarketed
02285959TEVA-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 200 MGMarketed
02285975TEVA-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 800 MGMarketed
02404044XERESEBAUSCH HEALTH, CANADA INC.CreamACYCLOVIR 5 %; HYDROCORTISONE 1 %Marketed
00569771ZOVIRAXBAUSCH HEALTH, CANADA INC.OintmentACYCLOVIR 5 %Marketed
02039524ZOVIRAXBAUSCH HEALTH, CANADA INC.CreamACYCLOVIR 5 %Marketed
02286572ACYCLOVIRSANIS HEALTH INCTabletACYCLOVIR 800 MGCancelled Post Market
02286556ACYCLOVIRSANIS HEALTH INCTabletACYCLOVIR 200 MGCancelled Post Market
02286564ACYCLOVIRSANIS HEALTH INCTabletACYCLOVIR 400 MGCancelled Post Market
02237541ACYCLOVIR-200PRO DOC LIMITEETabletACYCLOVIR 200 MGCancelled Post Market
02237542ACYCLOVIR-400PRO DOC LIMITEETabletACYCLOVIR 400 MGCancelled Post Market
02237543ACYCLOVIR-800PRO DOC LIMITEETabletACYCLOVIR 800 MGCancelled Post Market
02229708ALTI-ACYCLOVIR - 400MGALTIMED PHARMA INC.TabletACYCLOVIR 400 MGCancelled Post Market
02229709ALTI-ACYCLOVIR - 800MGALTIMED PHARMA INC.TabletACYCLOVIR 800 MGCancelled Post Market
02229707ALTI-ACYCLOVIR - TAB 200MGALTIMED PHARMA INC.TabletACYCLOVIR 200 MGCancelled Post Market
02367513NTP-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 200 MGCancelled Pre Market
02367521NTP-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 400 MGCancelled Pre Market
02367548NTP-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 800 MGCancelled Pre Market
02078627RATIO-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 200 MGCancelled Post Market
02078635RATIO-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 400 MGCancelled Post Market
02078651RATIO-ACYCLOVIRTEVA CANADA LIMITEDTabletACYCLOVIR 800 MGCancelled Post Market
02470098SITAVIGEPI HEALTH, LLCTabletACYCLOVIR 50 MGCancelled (Unreturned Annual)
00886157ZOVIRAXGLAXOSMITHKLINE INCSuspensionACYCLOVIR 200 MGCancelled Post Market
01911627ZOVIRAX 400GLAXOSMITHKLINE INCTabletACYCLOVIR 400 MGCancelled Post Market
01911635ZOVIRAX 800GLAXOSMITHKLINE INCTabletACYCLOVIR 800 MGCancelled Post Market
00590924ZOVIRAX CAP 200MGGLAXO WELLCOME INC.CapsuleACYCLOVIR 200 MGCancelled Post Market
00634506ZOVIRAX TAB 200MGGLAXOSMITHKLINE INCTabletACYCLOVIR 200 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
252102021-02-12New Drug Submission (NDS)CHANGE IN PRODUCT OWNERSHIP AND PRODUCT BRAND NAME CHANGE
48131995-11-29New Drug Submission (NDS)

International API supply for ACYCLOVIR

44 active FDA Drug Master Files.

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