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TARO-TACROLIMUS DIN 02453428

Status: Cancelled Pre Market
Holder: SUN PHARMA CANADA INC
Molecule: TACROLIMUS

Health Canada record

Active ingredient(s)TACROLIMUS 5 MG
Dosage formCapsule (Immediate-Release)
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL04AD02 TACROLIMUS
Original market date
Current status date06-Feb-2023
SourceHealth Canada DPD

Establishment licence of the holder

Sun Pharma Canada Inc. — licence 3-002572, currently licensed, last inspection rating C (2026-06-15).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TACROLIMUS

DINProductCompanyFormStrengthStatus
02456095ACH-TACROLIMUSACCORD HEALTHCARE INCCapsule (Immediate-Release)TACROLIMUS 1 MGMarketed
02454068ACH-TACROLIMUSACCORD HEALTHCARE INCCapsule (Immediate-Release)TACROLIMUS 0.5 MGMarketed
02456109ACH-TACROLIMUSACCORD HEALTHCARE INCCapsule (Immediate-Release)TACROLIMUS 5 MGMarketed
02296470ADVAGRAFASTELLAS PHARMA CANADA INCCapsule (Extended-Release)TACROLIMUS 1 MGMarketed
02296489ADVAGRAFASTELLAS PHARMA CANADA INCCapsule (Extended-Release)TACROLIMUS 5 MGMarketed
02331667ADVAGRAFASTELLAS PHARMA CANADA INCCapsule (Extended-Release)TACROLIMUS 3 MGMarketed
02296462ADVAGRAFASTELLAS PHARMA CANADA INCCapsule (Extended-Release)TACROLIMUS 0.5 MGMarketed
02459213APO-TACROLIMUSAPOTEX INCCapsule (Immediate-Release)TACROLIMUS 0.5 MGApproved
02474506APO-TACROLIMUS CAPSULESAPOTEX INCCapsule (Immediate-Release)TACROLIMUS 1 MGApproved
02474514APO-TACROLIMUS CAPSULESAPOTEX INCCapsule (Immediate-Release)TACROLIMUS 5 MGApproved
02485893ENVARSUS PAKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TACROLIMUS 4 MGMarketed
02485885ENVARSUS PAKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TACROLIMUS 1 MGMarketed
02485877ENVARSUS PAKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TACROLIMUS 0.75 MGMarketed
02569264JAMP TACROLIMUS OINTMENTJAMP PHARMA CORPORATIONOintmentTACROLIMUS 0.1 %Approved
02531380LEO PHARMA - TACROLIMUSLEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.OintmentTACROLIMUS 0.1 %Approved
02531399LEO PHARMA - TACROLIMUSLEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.OintmentTACROLIMUS 0.03 %Approved
02175983PROGRAFASTELLAS PHARMA CANADA INCCapsuleTACROLIMUS 5 MGMarketed
02175991PROGRAFASTELLAS PHARMA CANADA INCCapsuleTACROLIMUS 1 MGMarketed
02176009PROGRAFASTELLAS PHARMA CANADA INCSolutionTACROLIMUS 5 MGMarketed
02243144PROGRAFASTELLAS PHARMA CANADA INCCapsuleTACROLIMUS 0.5 MGMarketed
02244149PROTOPICLEO PHARMA INCOintmentTACROLIMUS 0.03 %Marketed
02244148PROTOPICLEO PHARMA INCOintmentTACROLIMUS 0.1 %Marketed
02528614SANDOZ TACROLIMUS XRSANDOZ CANADA INCORPORATEDCapsule (Extended-Release)TACROLIMUS 2 MGApproved
02528622SANDOZ TACROLIMUS XRSANDOZ CANADA INCORPORATEDCapsule (Extended-Release)TACROLIMUS 3 MGMarketed
02528592SANDOZ TACROLIMUS XRSANDOZ CANADA INCORPORATEDCapsule (Extended-Release)TACROLIMUS 0.5 MGMarketed
02528630SANDOZ TACROLIMUS XRSANDOZ CANADA INCORPORATEDCapsule (Extended-Release)TACROLIMUS 5 MGMarketed
02528606SANDOZ TACROLIMUS XRSANDOZ CANADA INCORPORATEDCapsule (Extended-Release)TACROLIMUS 1 MGMarketed
02460238JAMP-TACROLIMUSJAMP PHARMA CORPORATIONCapsule (Immediate-Release)TACROLIMUS 0.5 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
268732021-10-19Abbreviated New Drug Submission (ANDS)Administrative: Manufacturer and Product Name Change. Updating the Product Monograph and Labelling
179302016-03-24Abbreviated New Drug Submission (ANDS)

International API supply for TACROLIMUS

26 active FDA Drug Master Files.

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