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LUTALYSE DIN 00813605

Status: Marketed
Holder: ZOETIS CANADA INC
Molecule: DINOPROST (DINOPROST TROMETHAMINE)

Health Canada record

Active ingredient(s)DINOPROST (DINOPROST TROMETHAMINE) 5 MG
Dosage formSolution
RouteSubcutaneous; Intramuscular
SchedulePRESCRIPTION
ClassVeterinary
ATC
Original market date31-Dec-1989
Current status date30-Jan-2015
SourceHealth Canada DPD

Establishment licence of the holder

Zoetis Canada Inc — licence 102076, currently licensed, last inspection rating C (2023-10-05).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing DINOPROST (DINOPROST TROMETHAMINE)

DINProductCompanyFormStrengthStatus
02468697ENZAPROST TCEVA ANIMAL HEALTH INCSolutionDINOPROST (DINOPROST TROMETHAMINE) 5 MGMarketed
02460394LUTALYSE HCZOETIS CANADA INCSolutionDINOPROST (DINOPROST TROMETHAMINE) 12.5 MGApproved
00318736PROSTIN F2 ALPHAPFIZER CANADA ULCSolutionDINOPROST (DINOPROST TROMETHAMINE) 5 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
186532016-11-10Supplement to a New Drug Submission (SNDS)ALTERNATE MANUFACTURING SITE
174942015-11-20Supplement to a New Drug Submission (SNDS)CHANGE TO DOSING INFORMATION AND WARNINGS
165692015-01-29Supplement to a New Drug Submission (SNDS)ADDITIONAL INDIOCATION
161522014-10-03Supplement to a New Drug Submission (SNDS)ALTERNATE DRUG PRODUCT MANUFACTUIRNG SITE
152222014-02-10New Drug Submission (NDS)TRANSFER OF DRUG IDENTIFICATION NUMBER (DIN) HOLDER
79022006-04-19Supplement to a New Drug Submission (SNDS)CHANGE IN EXPIRATION DATE TO 24 MONTHS, CHANGE IN MANUFACTURING SITE, CHANGE IN FORMULATION, CHANGES IN MANUFACTURING AND ADDITIONAL PACKAGE SIZE - 100ML
76592005-12-19New Drug Submission (NDS)
61642001-10-24New Drug Submission (NDS)
67191997-08-19New Drug Submission (NDS)
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