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ALEMBIC-BOSENTAN DIN 02423065

Status: Approved
Holder: ALEMBIC PHARMACEUTICALS LIMITED
Molecule: BOSENTAN (BOSENTAN MONOHYDRATE)

Health Canada record

Active ingredient(s)BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC02KX01 BOSENTAN
Original market date
Current status date16-Dec-2021
SourceHealth Canada DPD

Establishment licence of the holder

Alembic Pharmaceuticals Canada Ltd — licence 102075, currently licensed, last inspection rating C (2025-09-23).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing BOSENTAN (BOSENTAN MONOHYDRATE)

DINProductCompanyFormStrengthStatus
02423057ALEMBIC-BOSENTANALEMBIC PHARMACEUTICALS LIMITEDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGApproved
02526395AURO-BOSENTANAURO PHARMA INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGApproved
02526409AURO-BOSENTANAURO PHARMA INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGApproved
02383020PMS-BOSENTANPHARMASCIENCE INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGMarketed
02383012PMS-BOSENTANPHARMASCIENCE INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGMarketed
02483130TARO-BOSENTANTARO PHARMACEUTICALS INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGMarketed
02483149TARO-BOSENTANTARO PHARMACEUTICALS INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGMarketed
02244981TRACLEERJANSSEN INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGMarketed
02244982TRACLEERJANSSEN INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGMarketed
02435403ACCEL-BOSENTANACCEL PHARMA INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Pre Market
02386194ACT BOSENTANACTAVIS PHARMA COMPANYTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Post Market
02386208ACT BOSENTANACTAVIS PHARMA COMPANYTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Post Market
02399202APO-BOSENTANAPOTEX INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGDormant
02399210APO-BOSENTANAPOTEX INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGDormant
02466538BIO-BOSENTANBIOMED PHARMATabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Post Market
02466546BIO-BOSENTANBIOMED PHARMATabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Post Market
02468522BOSENTANPANDA PHARMACEUTICALS INC.TabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Pre Market
02468530BOSENTANPANDA PHARMACEUTICALS INC.TabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Pre Market
02463555BOSENTANACTELION PHARMACEUTICALS LTDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Pre Market
02463563BOSENTANACTELION PHARMACEUTICALS LTDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Pre Market
02426463BOSENTAN TABLETSACCORD HEALTHCARE INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Post Market
02424037MAR-BOSENTANMARCAN PHARMACEUTICALS INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Pre Market
02424045MAR-BOSENTANMARCAN PHARMACEUTICALS INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Pre Market
02383497MYLAN-BOSENTANMYLAN PHARMACEUTICALS ULCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Post Market
02383500MYLAN-BOSENTANMYLAN PHARMACEUTICALS ULCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Post Market
02467984NAT-BOSENTANNATCO PHARMA (CANADA) INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGDormant
02467992NAT-BOSENTANNATCO PHARMA (CANADA) INCTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGDormant
02386275SANDOZ BOSENTANSANDOZ CANADA INCORPORATEDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Post Market
02386283SANDOZ BOSENTANSANDOZ CANADA INCORPORATEDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125 MGCancelled Post Market
02398419TEVA-BOSENTANTEVA CANADA LIMITEDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 125.0 MGCancelled Post Market
02398400TEVA-BOSENTANTEVA CANADA LIMITEDTabletBOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
272662021-12-16Abbreviated New Drug Submission (ANDS)Administrative: Change in Product Ownership
265492021-08-30Abbreviated New Drug Submission (ANDS)Administrative: Change in Product Ownership
235852020-05-12Abbreviated New Drug Submission (ANDS)TRANSFER OF DIN OWNERSHIP. PRODUCT NAME CHANGE
183862016-08-18Abbreviated New Drug Submission (ANDS)MERGER - BUYOUT
154522014-03-27Abbreviated New Drug Submission (ANDS)
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