APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR DIN 02468247
Health Canada record
| Active ingredient(s) | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ |
| Original market date | 04-Sep-2018 |
| Current status date | 04-Sep-2018 |
| 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 EFAVIRENZ
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02418428 | AURO-EFAVIRENZ | AURO PHARMA INC | Tablet | EFAVIRENZ 600 MG | Marketed |
| 02478404 | AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR | AURO PHARMA INC | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02519461 | JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | JAMP PHARMA CORPORATION | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02381524 | MYLAN-EFAVIRENZ | MYLAN PHARMACEUTICALS ULC | Tablet | EFAVIRENZ 600 MG | Marketed |
| 02461412 | MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | MYLAN PHARMACEUTICALS ULC | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02389762 | TEVA-EFAVIRENZ | TEVA CANADA LIMITED | Tablet | EFAVIRENZ 600 MG | Marketed |
| 02393549 | TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR | TEVA CANADA LIMITED | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02300699 | ATRIPLA | GILEAD SCIENCES, LLC | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Cancelled Post Market |
| 02458233 | JAMP-EFAVIRENZ | JAMP PHARMA CORPORATION | Tablet | EFAVIRENZ 600 MG | Dormant |
| 02487284 | PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR | PHARMASCIENCE INC | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Dormant |
| 02518716 | RIVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR | LABORATOIRE RIVA INC. | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Cancelled Post Market |
| 02484676 | SANDOZ EFAVIRENZ/EMTRICITABINE/TENOFOVIR | SANDOZ CANADA INCORPORATED | Tablet | EFAVIRENZ 600 MG; EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Cancelled Post Market |
| 02239887 | SUSTIVA 100MG | BRISTOL-MYERS SQUIBB CANADA | Capsule | EFAVIRENZ 100 MG | Cancelled Post Market |
| 02239888 | SUSTIVA 200MG | BRISTOL-MYERS SQUIBB CANADA | Capsule | EFAVIRENZ 200 MG | Cancelled Post Market |
| 02239886 | SUSTIVA 50MG | BRISTOL-MYERS SQUIBB CANADA | Capsule | EFAVIRENZ 50 MG | Cancelled Post Market |
| 02246045 | SUSTIVA TABLETS | BRISTOL-MYERS SQUIBB CANADA | Tablet | EFAVIRENZ 600 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19797 | 2017-09-14 | Abbreviated New Drug Submission (ANDS) |
International API supply for EFAVIRENZ
18 active FDA Drug Master Files.
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