ANDRIOL DIN 00782327
Health Canada record
| Active ingredient(s) | TESTOSTERONE UNDECANOATE 40 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | CONTROLLED DRUGS (CDSA IV) |
| Class | Human |
| ATC | G03BA03 TESTOSTERONE |
| Original market date | 31-Dec-1992 |
| Current status date | 29-Jan-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Merck Canada Inc — licence 101380, currently licensed, last inspection rating C (2023-07-17).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TESTOSTERONE UNDECANOATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02563797 | JATENZO | TOLMAR INTERNATIONAL LTD. | Capsule | TESTOSTERONE UNDECANOATE 237 MG | Marketed |
| 02563789 | JATENZO | TOLMAR INTERNATIONAL LTD. | Capsule | TESTOSTERONE UNDECANOATE 198 MG | Marketed |
| 02563770 | JATENZO | TOLMAR INTERNATIONAL LTD. | Capsule | TESTOSTERONE UNDECANOATE 158 MG | Marketed |
| 02562758 | KYZATREX | HIKMA CANADA LIMITED | Capsule | TESTOSTERONE UNDECANOATE 200 MG | Approved |
| 02562723 | KYZATREX | HIKMA CANADA LIMITED | Capsule | TESTOSTERONE UNDECANOATE 100 MG | Approved |
| 02562731 | KYZATREX | HIKMA CANADA LIMITED | Capsule | TESTOSTERONE UNDECANOATE 150 MG | Approved |
| 02421186 | TARO-TESTOSTERONE | TARO PHARMACEUTICALS INC | Capsule | TESTOSTERONE UNDECANOATE 40 MG | Marketed |
| 02322498 | PMS-TESTOSTERONE | PHARMASCIENCE INC | Capsule | TESTOSTERONE UNDECANOATE 40 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12071 | 2011-02-15 | New Drug Submission (NDS) | Manufacturer name change |
| 9983 | 2009-01-05 | New Drug Submission (NDS) | Manufacturer name change |
International API supply for TESTOSTERONE UNDECANOATE
8 active FDA Drug Master Files.
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