AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE DIN 02496356
Health Canada record
| Active ingredient(s) | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AR03 TENOFOVIR DISOPROXIL AND EMTRICITABINE |
| Original market date | 09-Nov-2020 |
| Current status date | 09-Nov-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Angita Pharma Inc. — licence 101870, currently licensed, last inspection rating C (2025-01-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EMTRICITABINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02452006 | APO-EMTRICITABINE-TENOFOVIR | APOTEX INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02490684 | AURO-EMTRICITABINE-TENOFOVIR | AURO PHARMA INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02374129 | COMPLERA | GILEAD SCIENCES CANADA INC | Tablet | EMTRICITABINE 200 MG; RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02454416 | DESCOVY | GILEAD SCIENCES CANADA INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 10 MG | Marketed |
| 02454424 | DESCOVY | GILEAD SCIENCES CANADA INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG | Marketed |
| 02487012 | JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | JAMP PHARMA CORPORATION | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02521547 | MINT-EMTRICITABINE/TENOFOVIR | MINT PHARMACEUTICALS INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02443902 | MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL | MYLAN PHARMACEUTICALS ULC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02461463 | ODEFSEY | GILEAD SCIENCES CANADA INC | Tablet | EMTRICITABINE 200 MG; RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25 MG; TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG | Marketed |
| 02461110 | PMS-EMTRICITABINE-TENOFOVIR | PHARMASCIENCE INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02399059 | TEVA-EMTRICITABINE/TENOFOVIR | TEVA CANADA LIMITED | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02274906 | TRUVADA | GILEAD SCIENCES CANADA INC | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Marketed |
| 02272091 | EMTRIVA | GILEAD SCIENCES CANADA INC | Capsule | EMTRICITABINE 200 MG | Cancelled Post Market |
| 02487853 | SANDOZ EMTRICITABINE-TENOFOVIR | SANDOZ CANADA INCORPORATED | Tablet | EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL FUMARATE 300 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23229 | 2020-02-19 | Abbreviated New Drug Submission (ANDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES |
International API supply for EMTRICITABINE
15 active FDA Drug Master Files.
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