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NAT-SUNITINIB DIN 02552906

Status: Marketed
Holder: NATCO PHARMA (CANADA) INC
Molecule: SUNITINIB (SUNITINIB MALATE)

Health Canada record

Active ingredient(s)SUNITINIB (SUNITINIB MALATE) 25 MG
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01EX01 SUNITINIB
Original market date30-Sep-2025
Current status date30-Sep-2025
SourceHealth Canada DPD

Establishment licence of the holder

Natco Pharma (Canada) Inc — licence 102058, currently licensed, last inspection rating C (2022-07-26).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SUNITINIB (SUNITINIB MALATE)

DINProductCompanyFormStrengthStatus
02532212AURO-SUNITINIBAURO PHARMA INCCapsuleSUNITINIB (SUNITINIB MALATE) 37.5 MGApproved
02532190AURO-SUNITINIBAURO PHARMA INCCapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGMarketed
02532204AURO-SUNITINIBAURO PHARMA INCCapsuleSUNITINIB (SUNITINIB MALATE) 25 MGMarketed
02532220AURO-SUNITINIBAURO PHARMA INCCapsuleSUNITINIB (SUNITINIB MALATE) 50 MGMarketed
02548062EUGIA-SUNITINIBEUGIA PHARMA INC.CapsuleSUNITINIB (SUNITINIB MALATE) 50 MGApproved
02548054EUGIA-SUNITINIBEUGIA PHARMA INC.CapsuleSUNITINIB (SUNITINIB MALATE) 37.5 MGApproved
02548046EUGIA-SUNITINIBEUGIA PHARMA INC.CapsuleSUNITINIB (SUNITINIB MALATE) 25 MGApproved
02548038EUGIA-SUNITINIBEUGIA PHARMA INC.CapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGApproved
02539284NAT-SUNITINIBNATCO PHARMA (CANADA) INCCapsuleSUNITINIB (SUNITINIB MALATE) 50 MGMarketed
02552892NAT-SUNITINIBNATCO PHARMA (CANADA) INCCapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGMarketed
02280795SUTENTPFIZER CANADA ULCCapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGMarketed
02280809SUTENTPFIZER CANADA ULCCapsuleSUNITINIB (SUNITINIB MALATE) 25 MGMarketed
02280817SUTENTPFIZER CANADA ULCCapsuleSUNITINIB (SUNITINIB MALATE) 50 MGMarketed
02524074TARO-SUNITINIBTARO PHARMACEUTICALS INCCapsuleSUNITINIB (SUNITINIB MALATE) 37.5 MGApproved
02524066TARO-SUNITINIBTARO PHARMACEUTICALS INCCapsuleSUNITINIB (SUNITINIB MALATE) 25 MGMarketed
02524058TARO-SUNITINIBTARO PHARMACEUTICALS INCCapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGMarketed
02524082TARO-SUNITINIBTARO PHARMACEUTICALS INCCapsuleSUNITINIB (SUNITINIB MALATE) 50 MGMarketed
02526220TEVA-SUNITINIBTEVA CANADA LIMITEDCapsuleSUNITINIB (SUNITINIB MALATE) 50 MGMarketed
02526212TEVA-SUNITINIBTEVA CANADA LIMITEDCapsuleSUNITINIB (SUNITINIB MALATE) 25 MGMarketed
02526204TEVA-SUNITINIBTEVA CANADA LIMITEDCapsuleSUNITINIB (SUNITINIB MALATE) 12.5 MGMarketed
02328607SUTENTPFIZER CANADA ULCCapsuleSUNITINIB (SUNITINIB MALATE) 37.5 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
343572024-11-12Supplement to an Abbreviated New Drug Submission (SANDS)Addition of new strength: 12.5 mg and 25 mg. Update to package labels
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