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OPTIRAY 320 (ULTRAJECT) DIN 02035626

Status: Dormant
Holder: LIEBEL-FLARSHEIM COMPANY LLC
Molecule: IOVERSOL

Health Canada record

Active ingredient(s)IOVERSOL 68 %
Dosage formSolution
RouteIntravascular
ScheduleETHICAL
ClassHuman
ATCV08AB07 IOVERSOL
Original market date05-Feb-1995
Current status date24-Jan-2025
SourceHealth Canada DPD

Establishment licence of the holder

Liebel-Flarsheim Canada Inc. — licence 102249, not currently licensed, last inspection rating C (2023-11-06).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing IOVERSOL

DINProductCompanyFormStrengthStatus
02387441OPTIRAY 300 (ULTRAJECT)LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 64 %Approved
01900838OPTIRAY 160TYCO HEALTHCARESolutionIOVERSOL 34 %Cancelled Post Market
02035618OPTIRAY 160 (ULTRAJECT)TYCO HEALTHCARESolutionIOVERSOL 34 %Cancelled Pre Market
02225263OPTIRAY 240LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 51 %Cancelled Post Market
02035332OPTIRAY 240 (ULTRAJECT)LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 51 %Cancelled Post Market
02034492OPTIRAY 300LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 64 %Dormant
01900854OPTIRAY 320LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 68 %Dormant
02034484OPTIRAY 350LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 74 %Dormant
02079992OPTIRAY 350 (ULTRAJECT)LIEBEL-FLARSHEIM COMPANY LLCSolutionIOVERSOL 74 %Dormant

Notices of Compliance

NOCDateSubmissionReason
271292021-11-30New Drug Submission (NDS)Administrative: Change in Product Ownership
165242015-01-13New Drug Submission (NDS)TRANSFER OF DRUG IDENTIFICATION NUMBERS
139222012-11-30New Drug Submission (NDS)Manufacturer name change
136692002-06-17New Drug Submission (NDS)Manufacturer name change

International API supply for IOVERSOL

4 active FDA Drug Master Files.

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