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SUROLAN DIN 00755753

Status: Marketed
Holder: ELANCO CANADA LIMITED
Molecule: MICONAZOLE NITRATE

Health Canada record

Active ingredient(s)MICONAZOLE NITRATE 23 MG; POLYMYXIN B SULFATE 0.5293 MG; PREDNISOLONE ACETATE 5 MG
Dosage formSuspension
RouteTopical; Otic
SchedulePRESCRIPTION
ClassVeterinary
ATC
Original market date31-Dec-1989
Current status date15-Mar-2019
SourceHealth Canada DPD

Establishment licence of the holder

Elanco Canada Limited — licence 102236, currently licensed, last inspection rating C (2022-08-03).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing MICONAZOLE NITRATE

DINProductCompanyFormStrengthStatus
02493454ADAXIO SHAMPOOCEVA ANIMAL HEALTH INCShampooMICONAZOLE NITRATE 2 %; CHLORHEXIDINE GLUCONATE 2 %Approved
02509725AURIMICVETVIVA RICHTER GMBHSuspensionMICONAZOLE NITRATE 23 MG; PREDNISOLONE ACETATE 5 MG; POLYMYXIN B SULFATE 0.5293 MGMarketed
02424576EASOTICVIRBAC AH, INC.SuspensionMICONAZOLE NITRATE 17.4 MG; GENTAMICIN (GENTAMICIN SULFATE) 1.5 MG; HYDROCORTISONE ACEPONATE 1.1 MGMarketed
02085852MICATIN MICONAZOLE NITRATE CREAM 2% USPWELLSPRING PHARMACEUTICAL CANADA CORPCreamMICONAZOLE NITRATE 2 %Marketed
02230304MICATIN POWDER SPRAY - UNSCENTED 2%WELLSPRING PHARMACEUTICAL CANADA CORPAerosolMICONAZOLE NITRATE 2 %Marketed
02171775MICONAZOLE 3 DAY OVULE TREATMENT 400MGVITA HEALTH PRODUCTS INCSuppositoryMICONAZOLE NITRATE 400 MGMarketed
02245546MICONAZOLE NITRATE VAGINAL CREAM 2%VITA HEALTH PRODUCTS INCCreamMICONAZOLE NITRATE 2 %Marketed
02231533MICONAZOLE NITRATE VAGINAL CREAM USP, 2%TARO PHARMACEUTICALS INCCreamMICONAZOLE NITRATE 2 %Marketed
02244005MONISTAT 3 VAGINAL CREAMINSIGHT PHARMACEUTICALS, LLCCreamMICONAZOLE NITRATE 4 %Marketed
02126257MONISTAT 7 DUAL-PAKINSIGHT PHARMACEUTICALS, LLCSuppository; CreamMICONAZOLE NITRATE 100 MG; MICONAZOLE NITRATE 2 %Marketed
02084309MONISTAT 7 VAGINAL CREAMINSIGHT PHARMACEUTICALS, LLCCreamMICONAZOLE NITRATE 2 %Marketed
02126567MONISTAT DERM CREAMINSIGHT PHARMACEUTICALS, LLCCreamMICONAZOLE NITRATE 2 %Marketed
02458888OTIZOLECAN-VET ANIMAL HEALTH SUPPLIES LTD.SuspensionMICONAZOLE NITRATE 23 MG; POLYMYXIN B SULFATE 0.5293 MG; PREDNISOLONE ACETATE 5 MGMarketed
00755745CONOFITEJANSSEN PHARMACEUTICA N.V.CreamMICONAZOLE NITRATE 20 MGCancelled Post Market
02194368MICONAZOLE 7 - CRM VAG 2%TECHNILAB PHARMA INC.CreamMICONAZOLE NITRATE 2 %Cancelled Post Market
02231106MICOZOLETARO PHARMACEUTICALS INCCreamMICONAZOLE NITRATE 2 %Cancelled Post Market
02219476MONAZOLE 7 - CRM 20MG/GTECHNILAB PHARMA INC.CreamMICONAZOLE NITRATE 20 MGCancelled Post Market
02239600MONISTAT 1 COMBINATION PACKINSIGHT PHARMACEUTICALS, LLCSuppository; CreamMICONAZOLE NITRATE 1200 MG; MICONAZOLE NITRATE 2 %Dormant
02239601MONISTAT 1 VAGINAL OVULEINSIGHT PHARMACEUTICALS, LLCSuppositoryMICONAZOLE NITRATE 1200 MGDormant
02126249MONISTAT 3 DUAL-PAKINSIGHT PHARMACEUTICALS, LLCOvule; CreamMICONAZOLE NITRATE 400 MG; MICONAZOLE NITRATE 2 %Dormant
02126605MONISTAT 3 VAGINAL OVULESINSIGHT PHARMACEUTICALS, LLCOvuleMICONAZOLE NITRATE 400 MGCancelled Post Market
02084295MONISTAT 7 SUP VAG 100MGMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INCSuppositoryMICONAZOLE NITRATE 100 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
215222018-11-13Supplement to a New Drug Submission (SNDS)addition manufacturing and testing site - drug substance
204282018-02-02New Drug Submission (NDS)MERGER - BUYOUT
188852017-01-19Supplement to a New Drug Submission (SNDS)LABELLING UPDATE
130792012-03-06New Drug Submission (NDS)Change in ownership
121422011-03-11New Drug Submission (NDS)Change in ownership
36452004-05-19New Drug Submission (NDS)

International API supply for MICONAZOLE NITRATE

3 valid EDQM Certificates of Suitability from 3 holders. 7 active FDA Drug Master Files.

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