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BIO-MONTELUKAST DIN 02553767

Status: Approved
Holder: BIOMED PHARMA
Molecule: MONTELUKAST (MONTELUKAST SODIUM)

Health Canada record

Active ingredient(s)MONTELUKAST (MONTELUKAST SODIUM) 5 MG
Dosage formTablet (Chewable)
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCR03DC03 MONTELUKAST
Original market date
Current status date05-Dec-2024
SourceHealth Canada DPD

Establishment licence of the holder

Biomed Pharma — licence 101061, currently licensed, last inspection rating C (2024-06-11).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing MONTELUKAST (MONTELUKAST SODIUM)

DINProductCompanyFormStrengthStatus
02379236ACH-MONTELUKASTACCORD HEALTHCARE INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02374609APO-MONTELUKASTAPOTEX INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02377608APO-MONTELUKASTAPOTEX INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02377616APO-MONTELUKASTAPOTEX INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02401274AURO-MONTELUKASTAURO PHARMA INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02391422JAMP-MONTELUKASTJAMP PHARMA CORPORATIONTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02399997MAR-MONTELUKASTMARCAN PHARMACEUTICALS INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02408643MINT-MONTELUKASTMINT PHARMACEUTICALS INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02408635MINT-MONTELUKASTMINT PHARMACEUTICALS INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02408627MINT-MONTELUKASTMINT PHARMACEUTICALS INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02379325MONTELUKASTSANIS HEALTH INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02379333MONTELUKASTSANIS HEALTH INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02379821MONTELUKASTPRO DOC LIMITEETablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02382474MONTELUKASTSIVEM PHARMACEUTICALS ULCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02382466MONTELUKASTSIVEM PHARMACEUTICALS ULCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02382458MONTELUKASTSIVEM PHARMACEUTICALS ULCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02379856MONTELUKASTPRO DOC LIMITEETabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02379848MONTELUKASTPRO DOC LIMITEETablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02354977PMS-MONTELUKASTPHARMASCIENCE INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02354985PMS-MONTELUKASTPHARMASCIENCE INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02373947PMS-MONTELUKAST FCPHARMASCIENCE INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02398826RIVA-MONTELUKAST FCLABORATOIRE RIVA INC.TabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02328593SANDOZ MONTELUKASTSANDOZ CANADA INCORPORATEDTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02358611SANDOZ MONTELUKASTSANDOZ CANADA INCORPORATEDGranulesMONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02330393SANDOZ MONTELUKASTSANDOZ CANADA INCORPORATEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02330385SANDOZ MONTELUKASTSANDOZ CANADA INCORPORATEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02243602SINGULAIRORGANON CANADA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02238216SINGULAIRORGANON CANADA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02238217SINGULAIRORGANON CANADA INC.TabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02389517SPC-MONTELUKASTSUN PHARMA CANADA INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02355523TEVA-MONTELUKASTTEVA CANADA LIMITEDTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGMarketed
02355507TEVA-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGMarketed
02355515TEVA-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGMarketed
02401150ACCEL-MONTELUKAST SODIUM TABLETSACCEL PHARMA INCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Pre Market
02410273ACH-MONTELUKASTACCORD HEALTHCARE INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Post Market
02410265ACH-MONTELUKASTACCORD HEALTHCARE INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02376679DOM-MONTELUKASTDOMINION PHARMACALTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02376687DOM-MONTELUKASTDOMINION PHARMACALTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Post Market
02376695DOM-MONTELUKAST FCDOMINION PHARMACALTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Post Market
02399865MAR-MONTELUKASTMARCAN PHARMACEUTICALS INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGDormant
02399873MAR-MONTELUKASTMARCAN PHARMACEUTICALS INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGDormant
02379317MONTELUKASTSANIS HEALTH INCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02380749MYLAN-MONTELUKASTMYLAN PHARMACEUTICALS ULCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02380757MYLAN-MONTELUKASTMYLAN PHARMACEUTICALS ULCTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Post Market
02368226MYLAN-MONTELUKASTMYLAN PHARMACEUTICALS ULCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Post Market
02376830NTP-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Pre Market
02376849NTP-MONTELUKASTTEVA CANADA LIMITEDTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Pre Market
02376822NTP-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Pre Market
02377586Q-MONTELUKASTQD PHARMACEUTICALS ULCTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Pre Market
02402807RAN-MONTELUKASTRANBAXY PHARMACEUTICALS CANADA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Post Market
02402793RAN-MONTELUKASTRANBAXY PHARMACEUTICALS CANADA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02336677RATIO-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Pre Market
02336669RATIO-MONTELUKASTTEVA CANADA LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Pre Market
02336685RATIO-MONTELUKASTTEVA CANADA LIMITEDTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled Pre Market
02398818RIVA-MONTELUKASTLABORATOIRE RIVA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled Pre Market
02398796RIVA-MONTELUKASTLABORATOIRE RIVA INC.Tablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Pre Market
02247997SINGULAIRORGANON CANADA INC.GranulesMONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled Post Market
02396815UNI-MONTELUKASTUNIMARK REMEDIES LIMITEDTabletMONTELUKAST (MONTELUKAST SODIUM) 10 MGCancelled (Unreturned Annual)
02396807UNI-MONTELUKASTUNIMARK REMEDIES LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 5 MGCancelled (Unreturned Annual)
02396793UNI-MONTELUKASTUNIMARK REMEDIES LIMITEDTablet (Chewable)MONTELUKAST (MONTELUKAST SODIUM) 4 MGCancelled (Unreturned Annual)

Notices of Compliance

NOCDateSubmissionReason
345112024-12-05Abbreviated New Drug Submission (ANDS)Administrative: Licensing Agreement between two manufacturers
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