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ALLEGRA 12 HOUR DIN 02231462

Status: Marketed
Holder: SANOFI CONSUMER HEALTH INC
Molecule: FEXOFENADINE HYDROCHLORIDE

Health Canada record

Active ingredient(s)FEXOFENADINE HYDROCHLORIDE 60 MG
Dosage formTablet
RouteOral
ScheduleNON-PRESCRIPTION DRUGS
ClassHuman
ATCR06AX26 FEXOFENADINE
Original market date10-Jul-1997
Current status date15-Nov-2019
SourceHealth Canada DPD

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing FEXOFENADINE HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02242819ALLEGRA 24 HOURSANOFI CONSUMER HEALTH INCTabletFEXOFENADINE HYDROCHLORIDE 120 MGMarketed
02521245ALLEGRA HIVESSANOFI CONSUMER HEALTH INCTabletFEXOFENADINE HYDROCHLORIDE 60 MGMarketed
02239853ALLEGRA-DSANOFI CONSUMER HEALTH INCTablet (Immediate- And Extended-Release)FEXOFENADINE HYDROCHLORIDE 60 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
268682021-10-18Supplement to a New Drug Submission (SNDS)NEW PRODUCT DIN. UPDATES TO THE PRODUCT MONOGRAPH
229122019-11-15New Drug Submission (NDS)Administrative: Change in Product Ownership
204852018-02-13Supplement to a New Drug Submission (SNDS)REVISION OF THE INNER AND OUTER PRODUCT LABELLING IN COMPLIANCE WITH THE PLAIN LANGUAGE LABELLING REGULATIONS AND REVISIONS TO THE PRODUCT MONOGRAPH (PM) AS FOLLOWS: REMOVAL OF INFORMATION [ERTAINING TO ALLEGRA 60 MG CAPSULES FROM THE PM FOLLOWING DISCONTINUATION OF THE DRUG IDENTIFICATION NUMBER (DIN); ADDITION OF NEW FORMAT SIZES (30 AND 48 TABLETS) TO THE PM FOR ALLEGRA 12 HOUR AND ALLEGRA 24 HOUR; CREATION OF TWO 'PATIENT INFORMATION INFORMATION' SECTION IN THE PM FOR ALLEGRA 12 HOUR AND ALLEGRA 24 HOUR
79512006-05-11New Drug Submission (NDS)MANUFACTURER NAME CHANGE
22822001-01-24Supplement to a New Drug Submission (SNDS)PRODUCT NAME CHANGE FROM ALLEGRA
11672000-06-12New Drug Submission (NDS)
38001997-06-11New Drug Submission (NDS)

International API supply for FEXOFENADINE HYDROCHLORIDE

7 valid EDQM Certificates of Suitability from 7 holders. 16 active FDA Drug Master Files.

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