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NALOXONE HYDROCHLORIDE INJECTION, USP DIN 02534967

Status: Approved
Holder: EUGIA PHARMA INC.
Molecule: NALOXONE HYDROCHLORIDE

Health Canada record

Active ingredient(s)NALOXONE HYDROCHLORIDE 0.4 MG
Dosage formSolution
RouteIntravenous; Subcutaneous; Intramuscular
SchedulePRESCRIPTION
ClassHuman
ATCV03AB15 NALOXONE
Original market date
Current status date06-Feb-2023
SourceHealth Canada DPD

Establishment licence of the holder

Eugia Pharma Inc. — licence 3-002768, currently licensed, last inspection rating C (2026-02-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing NALOXONE HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02555441KLOXXADOHIKMA CANADA LIMITEDSpray (Metered-Dose)NALOXONE HYDROCHLORIDE 8 MGApproved
02148706NALOXONE HCL INJECTION - 0.4MG/ML USPSANDOZ CANADA INCORPORATEDLiquidNALOXONE HYDROCHLORIDE 0.4 MGMarketed
02148714NALOXONE HCL INJECTION - 1MG/ML USPSANDOZ CANADA INCORPORATEDLiquidNALOXONE HYDROCHLORIDE 1 MGMarketed
02548194NALOXONE HYDROCHLORIDE INJECTION USPSTERINOVA INC.SolutionNALOXONE HYDROCHLORIDE 0.4 MGMarketed
02515261NALOXONE HYDROCHLORIDE INJECTION, USPAURO PHARMA INCSolutionNALOXONE HYDROCHLORIDE 0.4 MGApproved
02515288NALOXONE HYDROCHLORIDE INJECTION, USPAURO PHARMA INCSolutionNALOXONE HYDROCHLORIDE 4 MGApproved
02534975NALOXONE HYDROCHLORIDE INJECTION, USPEUGIA PHARMA INC.SolutionNALOXONE HYDROCHLORIDE 4 MGMarketed
02518074NALOXONE HYDROCHLORIDE INJECTION, USPBAXTER CORPORATIONSolutionNALOXONE HYDROCHLORIDE 0.4 MGApproved
02518066NALOXONE HYDROCHLORIDE INJECTION, USPBAXTER CORPORATIONSolutionNALOXONE HYDROCHLORIDE 0.4 MGApproved
02458578NALOXONE INJECTABLEHIKMA CANADA LIMITEDSolutionNALOXONE HYDROCHLORIDE 0.4 MGMarketed
02458187NARCAN NASAL SPRAYEMERGENT OPERATIONS IRELAND LIMITEDSpray (Metered-Dose)NALOXONE HYDROCHLORIDE 4 MGMarketed
02458179NARCAN NASAL SPRAYEMERGENT OPERATIONS IRELAND LIMITEDSpray (Metered-Dose)NALOXONE HYDROCHLORIDE 2 MGApproved
02453258S.O.S. NALOXONE HYDROCHLORIDE INJECTIONSANDOZ CANADA INCORPORATEDSolutionNALOXONE HYDROCHLORIDE 0.4 MGMarketed
02511568TEVA-NALOXONE NASAL SPRAYTEVA CANADA LIMITEDSpray (Metered-Dose)NALOXONE HYDROCHLORIDE 4 MGMarketed
01913948NARCAN INJECTION 0.02MG/MLBRISTOL-MYERS SQUIBB CANADALiquidNALOXONE HYDROCHLORIDE 0.02 MGCancelled Post Market
01913956NARCAN INJECTION 0.4MG/MLBRISTOL-MYERS SQUIBB CANADASolutionNALOXONE HYDROCHLORIDE 0.4 MGCancelled Post Market
01913964NARCAN INJECTION 1MG/MLBRISTOL-MYERS SQUIBB CANADALiquidNALOXONE HYDROCHLORIDE 1 MGCancelled Post Market
02453266S.O.S. NALOXONE HYDROCHLORIDE INJECTIONSANDOZ CANADA INCORPORATEDSolutionNALOXONE HYDROCHLORIDE 1 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
300572023-02-06Abbreviated New Drug Submission (ANDS)Administrative: Licensing Agreement Between Two Companies

International API supply for NALOXONE HYDROCHLORIDE

8 active FDA Drug Master Files.

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