Drug · DIN 02403161
APO-AMITRIPTYLINE
Authorized, but not sold for a year or more
Authorized, but the company reports it has not been sold in Canada for at least 12 months.
Status Dormant since March 22, 2026; first marketed June 12, 2013.
- Drug Identification Number (DIN)
- 02403161
- Company (DIN owner)
- Apotex Inc.Toronto, Ontario, Canada
- Schedule
- Prescription
- Dosage form
- Tablet
- Route
- Oral
- Therapeutic class (ATC)
- Amitriptyline N06AA09
- Class
- Human
- Record last updated
- April 23, 2026
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | 75 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- March 19, 2013: NOC 14226New Drug Submission (NDS) · New manufacturer and product name
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “apo-amitriptyline”. A notice may cover another product or only some lots: read it to see what it covers.
- Apo-Amitriptyline: Affected lots may exceed the interim acceptable intake limit for NNORTOctober 17, 2024 · Drugs · Product safety · Type I
- APO-AMITRIPTYLINE Tablets: NNORT impurityAugust 14, 2023 · Drugs · Contamination · Type I
- Amitriptyline antidepressant drugs recalled because of a nitrosamine impurityFebruary 7, 2023 · Drugs · Contamination - Product safety
- APO-AMITRIPTYLINE 10mg: NDMA ImpurityFebruary 7, 2023 · Drugs · Contamination - Product safety · Type I
- APO-AMITRIPTYLINE 10mg: NDMA impurityJanuary 26, 2022 · Drugs · Product safety · Type I
- APO-AMITRIPTYLINE 10mg (2021-04-29)April 29, 2021 · Drugs · Product safety · Type I
- APO-AMITRIPTYLINE 10mg (2021-04-13)April 13, 2021 · Drugs · Product safety · Type I
Other DINs named APO-AMITRIPTYLINE
- DIN 02403137 · Dormant
- DIN 02403145 · Dormant
- DIN 02403153 · Dormant