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FULVESTRANT INJECTION DIN 02533111

Status: Approved
Holder: AURO PHARMA INC
Molecule: FULVESTRANT

Health Canada record

Active ingredient(s)FULVESTRANT 250 MG
Dosage formSolution
RouteIntramuscular
SchedulePRESCRIPTION
ClassHuman
ATCL02BA03 FULVESTRANT
Original market date
Current status date06-Dec-2022
SourceHealth Canada DPD

Establishment licence of the holder

Auro Pharma Inc — licence 101305, currently licensed, last inspection rating C (2023-09-27).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing FULVESTRANT

DINProductCompanyFormStrengthStatus
02486350APO-FULVESTRANTAPOTEX INCSolutionFULVESTRANT 250 MGApproved
02248624FASLODEXASTRAZENECA CANADA INCSolutionFULVESTRANT 250 MGMarketed
02530635FULVESTRANT INJECTABLEJAMP PHARMA CORPORATIONSolutionFULVESTRANT 250 MGMarketed
02536293FULVESTRANT INJECTIONFORMATIVE PHARMA INC.SolutionFULVESTRANT 250 MGMarketed
02558971FULVESTRANT INJECTIONSTERIMAX INCSolutionFULVESTRANT 250 MGMarketed
02483610FULVESTRANT INJECTIONSANDOZ CANADA INCORPORATEDSolutionFULVESTRANT 250 MGMarketed
02536668FULVESTRANT INJECTIONEUGIA PHARMA INC.SolutionFULVESTRANT 250 MGApproved
02460130TEVA-FULVESTRANT INJECTIONTEVA CANADA LIMITEDSolutionFULVESTRANT 250 MGMarketed
02463075ACT FULVESTRANTACTAVIS PHARMA COMPANYSolutionFULVESTRANT 50 MGCancelled Pre Market
02486792FULVESTRANT INJECTIONACCORD HEALTHCARE INCSolutionFULVESTRANT 50 MGCancelled Post Market
02468549FULVESTRANT INJECTIONMYLAN PHARMACEUTICALS ULCSolutionFULVESTRANT 50 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
296412022-12-06Abbreviated New Drug Submission (ANDS)

International API supply for FULVESTRANT

8 valid EDQM Certificates of Suitability from 8 holders. 15 active FDA Drug Master Files.

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