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REDDY-SAPROPTERIN DIN 02534533

Status: Marketed
Holder: DR REDDY'S LABORATORIES LTD
Molecule: SAPROPTERIN DIHYDROCHLORIDE

Health Canada record

Active ingredient(s)SAPROPTERIN DIHYDROCHLORIDE 100 MG
Dosage formPowder For Solution
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCA16AX07 SAPROPTERIN
Original market date11-Dec-2023
Current status date11-Dec-2023
SourceHealth Canada DPD

Establishment licence of the holder

Dr Reddy's Laboratories (UK) Limited — licence , not currently licensed, last inspection rating C (2019-02-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SAPROPTERIN DIHYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02547481ALOG-SAPROPTERINANALOG PHARMA CANADA INC.TabletSAPROPTERIN DIHYDROCHLORIDE 100 MGApproved
02350580KUVANBIOMARIN INTERNATIONAL LIMITEDTabletSAPROPTERIN DIHYDROCHLORIDE 100 MGMarketed
02482207KUVANBIOMARIN INTERNATIONAL LIMITEDPowderSAPROPTERIN DIHYDROCHLORIDE 100 MGMarketed
02535610REDDY-SAPROPTERINDR REDDY'S LABORATORIES LTDPowder For SolutionSAPROPTERIN DIHYDROCHLORIDE 500 MGMarketed
02482215KUVANBIOMARIN INTERNATIONAL LIMITEDPowderSAPROPTERIN DIHYDROCHLORIDE 500 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
319632023-10-31Abbreviated New Drug Submission (ANDS)

International API supply for SAPROPTERIN DIHYDROCHLORIDE

8 active FDA Drug Master Files.

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