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LUPIN-TOLVAPTAN DIN 02557177

Status: Marketed
Holder: LUPIN PHARMA CANADA LIMITED
Molecule: TOLVAPTAN

Health Canada record

Active ingredient(s)TOLVAPTAN 15 MG; TOLVAPTAN 15 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC03XA01 TOLVAPTAN
Original market date21-Jan-2026
Current status date21-Jan-2026
SourceHealth Canada DPD

Establishment licence of the holder

Lupin Pharma Canada Limited — licence 102119, currently licensed, last inspection rating C (2025-07-22).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TOLVAPTAN

DINProductCompanyFormStrengthStatus
02437538JINARCOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 90 MG; TOLVAPTAN 30 MGMarketed
02491583JINARCOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 30 MG; TOLVAPTAN 15 MGMarketed
02491575JINARCOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 15 MG; TOLVAPTAN 15 MGMarketed
02437503JINARCOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 45 MG; TOLVAPTAN 15 MGMarketed
02437511JINARCOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 60 MG; TOLVAPTAN 30 MGMarketed
02557215LUPIN-TOLVAPTANLUPIN PHARMA CANADA LIMITEDTabletTOLVAPTAN 90 MG; TOLVAPTAN 30 MGMarketed
02557185LUPIN-TOLVAPTANLUPIN PHARMA CANADA LIMITEDTabletTOLVAPTAN 30 MG; TOLVAPTAN 15 MGMarketed
02557193LUPIN-TOLVAPTANLUPIN PHARMA CANADA LIMITEDTabletTOLVAPTAN 45 MG; TOLVAPTAN 15 MGMarketed
02557207LUPIN-TOLVAPTANLUPIN PHARMA CANADA LIMITEDTabletTOLVAPTAN 60 MG; TOLVAPTAN 30 MGMarketed
02370484SAMSCAOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 60 MGApproved
02370476SAMSCAOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 30 MGMarketed
02370468SAMSCAOTSUKA PHARMACEUTICAL CO LTDTabletTOLVAPTAN 15 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
352592025-04-25Abbreviated New Drug Submission (ANDS)

International API supply for TOLVAPTAN

19 active FDA Drug Master Files.

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