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ACT TADALAFIL DIN 02428628

Status: Cancelled Pre Market
Holder: TEVA CANADA LIMITED
Molecule: TADALAFIL

Health Canada record

Active ingredient(s)TADALAFIL 2.5 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCG04BE08 TADALAFIL
Original market date12-Jul-2016
Current status date30-Jul-2025
SourceHealth Canada DPD

Establishment licence of the holder

Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TADALAFIL

DINProductCompanyFormStrengthStatus
02422115APO-TADALAFILAPOTEX INCTabletTADALAFIL 20 MGMarketed
02422085APO-TADALAFILAPOTEX INCTabletTADALAFIL 2.5 MGMarketed
02422093APO-TADALAFILAPOTEX INCTabletTADALAFIL 5 MGMarketed
02422107APO-TADALAFILAPOTEX INCTabletTADALAFIL 10 MGMarketed
02421933APO-TADALAFIL PAHAPOTEX INCTabletTADALAFIL 20 MGMarketed
02435942AURO-TADALAFILAURO PHARMA INCTabletTADALAFIL 20 MGMarketed
02435934AURO-TADALAFILAURO PHARMA INCTabletTADALAFIL 10 MGMarketed
02435926AURO-TADALAFILAURO PHARMA INCTabletTADALAFIL 5 MGMarketed
02435896AURO-TADALAFILAURO PHARMA INCTabletTADALAFIL 2.5 MGMarketed
02248088CIALISELI LILLY CANADA INCTabletTADALAFIL 10 MGMarketed
02296888CIALISELI LILLY CANADA INCTabletTADALAFIL 2.5 MGMarketed
02296896CIALISELI LILLY CANADA INCTabletTADALAFIL 5 MGMarketed
02248089CIALISELI LILLY CANADA INCTabletTADALAFIL 20 MGMarketed
02448653IPG-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 2.5 MGApproved
02448661IPG-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 5 MGApproved
02448688IPG-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 10 MGApproved
02448696IPG-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 20 MGApproved
02451832JAMP-TADALAFILJAMP PHARMA CORPORATIONTabletTADALAFIL 5 MGMarketed
02451840JAMP-TADALAFILJAMP PHARMA CORPORATIONTabletTADALAFIL 10 MGMarketed
02451859JAMP-TADALAFILJAMP PHARMA CORPORATIONTabletTADALAFIL 20 MGMarketed
02452251MAR-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 10 MGMarketed
02452278MAR-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 5 MGMarketed
02452243MAR-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 20 MGMarketed
02451689MINT-TADALAFILMINT PHARMACEUTICALS INCTabletTADALAFIL 10 MGMarketed
02451670MINT-TADALAFILMINT PHARMACEUTICALS INCTabletTADALAFIL 5 MGMarketed
02451697MINT-TADALAFILMINT PHARMACEUTICALS INCTabletTADALAFIL 20 MGMarketed
02451662MINT-TADALAFILMINT PHARMACEUTICALS INCTabletTADALAFIL 2.5 MGApproved
02410621MYLAN-TADALAFILMYLAN PHARMACEUTICALS ULCTabletTADALAFIL 2.5 MGMarketed
02410648MYLAN-TADALAFILMYLAN PHARMACEUTICALS ULCTabletTADALAFIL 5 MGMarketed
02410664MYLAN-TADALAFILMYLAN PHARMACEUTICALS ULCTabletTADALAFIL 20 MGMarketed
02410656MYLAN-TADALAFILMYLAN PHARMACEUTICALS ULCTabletTADALAFIL 10 MGMarketed
02452480NRA-TADALAFIL TABLETSNORA PHARMA INCTabletTADALAFIL 5 MGMarketed
02452499NRA-TADALAFIL TABLETSNORA PHARMA INCTabletTADALAFIL 10 MGMarketed
02409437PMS-TADALAFILPHARMASCIENCE INCTabletTADALAFIL 10 MGMarketed
02409445PMS-TADALAFILPHARMASCIENCE INCTabletTADALAFIL 20 MGMarketed
02409429PMS-TADALAFILPHARMASCIENCE INCTabletTADALAFIL 5 MGMarketed
02409410PMS-TADALAFILPHARMASCIENCE INCTabletTADALAFIL 2.5 MGMarketed
02441101TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 5 MGApproved
02441098TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 2.5 MGApproved
02441136TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 20 MGApproved
02441128TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 10 MGApproved
02452111TARO-TADALAFILSUN PHARMA CANADA INCTabletTADALAFIL 20 MGMarketed
02452073TARO-TADALAFILSUN PHARMA CANADA INCTabletTADALAFIL 5 MGMarketed
02440156TEVA-TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 5 MGMarketed
02440164TEVA-TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 10 MGMarketed
02440172TEVA-TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 20 MGMarketed
02440148TEVA-TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 2.5 MGMarketed
02428636ACT TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 5 MGCancelled Pre Market
02428644ACT TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 10 MGCancelled Pre Market
02428652ACT TADALAFILTEVA CANADA LIMITEDTabletTADALAFIL 20 MGCancelled Pre Market
02338327ADCIRCAELI LILLY CANADA INCTabletTADALAFIL 20 MGCancelled Post Market
02437937DOM-TADALAFILDOMINION PHARMACALTabletTADALAFIL 20 MGCancelled Pre Market
02437929DOM-TADALAFILDOMINION PHARMACALTabletTADALAFIL 10 MGCancelled Pre Market
02437910DOM-TADALAFILDOMINION PHARMACALTabletTADALAFIL 5 MGCancelled Pre Market
02437902DOM-TADALAFILDOMINION PHARMACALTabletTADALAFIL 2.5 MGCancelled Pre Market
02451824JAMP-TADALAFILJAMP PHARMA CORPORATIONTabletTADALAFIL 2.5 MGDormant
02452286MAR-TADALAFILMARCAN PHARMACEUTICALS INCTabletTADALAFIL 2.5 MGDormant
02452472NRA-TADALAFIL TABLETSNORA PHARMA INCTabletTADALAFIL 2.5 MGDormant
02452081TARO-TADALAFILSUN PHARMA CANADA INCTabletTADALAFIL 2.5 MGDormant
02452103TARO-TADALAFILSUN PHARMA CANADA INCTabletTADALAFIL 10 MGDormant

Notices of Compliance

NOCDateSubmissionReason
233412020-03-16Abbreviated New Drug Submission (ANDS)Updated labelling materials Administrative: Merger/Buy-out
182492016-07-12Abbreviated New Drug Submission (ANDS)

International API supply for TADALAFIL

21 valid EDQM Certificates of Suitability from 21 holders. 27 active FDA Drug Master Files.

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