NRA-DUTASTERIDE DIN 02490587
Health Canada record
| Active ingredient(s) | DUTASTERIDE 0.5 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04CB02 DUTASTERIDE |
| Original market date | 16-Jun-2020 |
| Current status date | 02-Jan-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Nora Pharma Inc — licence 3-002506, currently licensed, last inspection rating C (2022-11-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DUTASTERIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02485672 | AG-DUTASTERIDE | ANGITA PHARMA INC. | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02404206 | APO-DUTASTERIDE | APOTEX INC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02469308 | AURO-DUTASTERIDE | AURO PHARMA INC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02247813 | AVODART | GLAXOSMITHKLINE INC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02443058 | DUTASTERIDE | SANIS HEALTH INC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02429012 | DUTASTERIDE | SIVEM PHARMACEUTICALS ULC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02427842 | DUTASTERIDE CAPSULES | STRIDES PHARMA CANADA INC | Capsule | DUTASTERIDE 0.5 MG | Approved |
| 02372010 | JALYN | GLAXOSMITHKLINE INC | Capsule (Immediate- And Extended-Release | DUTASTERIDE 0.5 MG; TAMSULOSIN HYDROCHLORIDE 0.4 MG | Marketed |
| 02546167 | JAMP DUTASTERIDE CAPSULES | JAMP PHARMA CORPORATION | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02428873 | MINT-DUTASTERIDE | MINT PHARMACEUTICALS INC | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02543990 | PRO-DUTASTERIDE | PRO DOC LIMITEE | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02424444 | SANDOZ DUTASTERIDE | SANDOZ CANADA INCORPORATED | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02408287 | TEVA-DUTASTERIDE | TEVA CANADA LIMITED | Capsule | DUTASTERIDE 0.5 MG | Marketed |
| 02412691 | ACT DUTASTERIDE | TEVA CANADA LIMITED | Capsule | DUTASTERIDE 0.5 MG | Cancelled Post Market |
| 02421712 | DUTASTERIDE | PRO DOC LIMITEE | Capsule | DUTASTERIDE 0.5 MG | Cancelled Post Market |
| 02484870 | JAMP DUTASTERIDE | JAMP PHARMA CORPORATION | Capsule | DUTASTERIDE 0.5 MG | Dormant |
| 02416298 | MED-DUTASTERIDE | GENERIC MEDICAL PARTNERS INC | Capsule | DUTASTERIDE 0.5 MG | Dormant |
| 02393220 | PMS-DUTASTERIDE | PHARMASCIENCE INC | Capsule | DUTASTERIDE 0.5 MG | Dormant |
| 02427753 | RIVA-DUTASTERIDE | LABORATOIRE RIVA INC. | Capsule | DUTASTERIDE 0.5 MG | Dormant |
| 02434369 | SANDOZ DUTASTERIDE | SANDOZ CANADA INCORPORATED | Capsule | DUTASTERIDE 0.5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32445 | 2024-01-02 | Supplement to an Abbreviated New Drug Submission (SANDS) | |
| 27933 | 2022-04-07 | Abbreviated New Drug Submission (ANDS) | Administrative: Change in Product Ownership. Administrative: Licensing Agreement Between Two Companies |
| 22408 | 2019-07-17 | Abbreviated New Drug Submission (ANDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES |
International API supply for DUTASTERIDE
4 valid EDQM Certificates of Suitability from 4 holders. 9 active FDA Drug Master Files.
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