APO-DULOXETINE DIN 02440431

Status: Marketed

Holder: APOTEX INC

Molecule: DULOXETINE (DULOXETINE HYDROCHLORIDE)

Available to quote

Health Canada record

Active ingredient(s)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG
Dosage form	Capsule (Delayed-Release)
Route	Oral
Schedule	PRESCRIPTION
Class	Human
ATC	N06AX21 DULOXETINE
Original market date	03-May-2016
Current status date	03-May-2016
Source	Health Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing DULOXETINE (DULOXETINE HYDROCHLORIDE)

DIN	Product	Company	Form	Strength	Status
02475316	AG-DULOXETINE	ANGITA PHARMA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02475308	AG-DULOXETINE	ANGITA PHARMA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02481960	ALTA-DULOXETINE	ALTAMED PHARMA	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02481952	ALTA-DULOXETINE	ALTAMED PHARMA	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02440423	APO-DULOXETINE	APOTEX INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02436647	AURO-DULOXETINE	AURO PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02436655	AURO-DULOXETINE	AURO PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02507722	BIO-DULOXETINE	BIOMED PHARMA	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02453630	DULOXETINE	SIVEM PHARMACEUTICALS ULC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02495090	DULOXETINE	LABORATOIRE RIVA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02495082	DULOXETINE	LABORATOIRE RIVA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02432331	DULOXETINE	ALEMBIC PHARMACEUTICALS LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Approved
02432447	DULOXETINE	ALEMBIC PHARMACEUTICALS LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Approved
02453649	DULOXETINE	SIVEM PHARMACEUTICALS ULC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02438089	IPG-DULOXETINE	MARCAN PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Approved
02438097	IPG-DULOXETINE	MARCAN PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Approved
02496518	JAMP DULOXETINE	JAMP PHARMA CORPORATION	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Approved
02496496	JAMP DULOXETINE	JAMP PHARMA CORPORATION	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Approved
02451921	JAMP-DULOXETINE	JAMP PHARMA CORPORATION	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02451913	JAMP-DULOXETINE	JAMP PHARMA CORPORATION	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02473216	M-DULOXETINE	MANTRA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02473208	M-DULOXETINE	MANTRA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02446081	MAR-DULOXETINE	MARCAN PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02446103	MAR-DULOXETINE	MARCAN PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02438984	MINT-DULOXETINE	MINT PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02438992	MINT-DULOXETINE	MINT PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02482134	NRA-DULOXETINE	NORA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02482126	NRA-DULOXETINE	NORA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02429446	PMS-DULOXETINE	PHARMASCIENCE INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02429454	PMS-DULOXETINE	PHARMASCIENCE INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02452669	PRO-DULOXETINE	PRO DOC LIMITEE	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02452650	PRO-DULOXETINE	PRO DOC LIMITEE	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02439956	SANDOZ DULOXETINE	SANDOZ CANADA INCORPORATED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02439948	SANDOZ DULOXETINE	SANDOZ CANADA INCORPORATED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02457202	TARO-DULOXETINE	TARO PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02457199	TARO-DULOXETINE	TARO PHARMACEUTICALS INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02456753	TEVA-DULOXETINE	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Marketed
02456761	TEVA-DULOXETINE	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Marketed
02301490	CYMBALTA	ELI LILLY CANADA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02301482	CYMBALTA	ELI LILLY CANADA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02453371	DOM-DULOXETINE	DOMINION PHARMACAL	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Pre Market
02453398	DOM-DULOXETINE	DOMINION PHARMACAL	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Pre Market
02490889	DULOXETINE	SANIS HEALTH INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Dormant
02490897	DULOXETINE	SANIS HEALTH INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Dormant
02437090	DULOXETINE DR	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02437082	DULOXETINE DR	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02426633	MYLAN-DULOXETINE	MYLAN PHARMACEUTICALS ULC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02426641	MYLAN-DULOXETINE	MYLAN PHARMACEUTICALS ULC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02490420	PRIVA-DULOXETINE	NORA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02490412	PRIVA-DULOXETINE	NORA PHARMA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02438259	RAN-DULOXETINE	RANBAXY PHARMACEUTICALS CANADA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02438267	RAN-DULOXETINE	RANBAXY PHARMACEUTICALS CANADA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02451077	RIVA-DULOXETINE	LABORATOIRE RIVA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Post Market
02451085	RIVA-DULOXETINE	LABORATOIRE RIVA INC.	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Post Market
02462109	STR-DULOXETINE	STAR - PHARMA PAN - AMERICA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Pre Market
02462095	STR-DULOXETINE	STAR - PHARMA PAN - AMERICA INC	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Pre Market
02436817	TEVA-DULOXETINE DR	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled Pre Market
02436825	TEVA-DULOXETINE DR	TEVA CANADA LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled Pre Market
02447029	TORRENT-DULOXETINE	TORRENT PHARMACEUTICALS LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 30 MG	Cancelled (Unreturned Annual)
02447037	TORRENT-DULOXETINE	TORRENT PHARMACEUTICALS LIMITED	Capsule (Delayed-Release)	DULOXETINE (DULOXETINE HYDROCHLORIDE) 60 MG	Cancelled (Unreturned Annual)

Notices of Compliance

NOC	Date	Submission	Reason
18044	2016-05-02	Abbreviated New Drug Submission (ANDS)

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