AG-SILODOSIN DIN 02541335
Health Canada record
| Active ingredient(s) | SILODOSIN 8 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04CA04 SILODOSIN |
| Original market date | |
| Current status date | 11-Sep-2023 |
| 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 SILODOSIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02541327 | AG-SILODOSIN | ANGITA PHARMA INC. | Capsule | SILODOSIN 4 MG | Approved |
| 02479850 | APO-SILODOSIN | APOTEX INC | Capsule | SILODOSIN 4 MG | Approved |
| 02478501 | AURO-SILODOSIN | AURO PHARMA INC | Capsule | SILODOSIN 4 MG | Marketed |
| 02478528 | AURO-SILODOSIN | AURO PHARMA INC | Capsule | SILODOSIN 8 MG | Marketed |
| 02539519 | JAMP SILODOSIN | JAMP PHARMA CORPORATION | Capsule | SILODOSIN 4 MG | Marketed |
| 02539527 | JAMP SILODOSIN | JAMP PHARMA CORPORATION | Capsule | SILODOSIN 8 MG | Marketed |
| 02517779 | PMS-SILODOSIN | PHARMASCIENCE INC | Capsule | SILODOSIN 4 MG | Marketed |
| 02517787 | PMS-SILODOSIN | PHARMASCIENCE INC | Capsule | SILODOSIN 8 MG | Marketed |
| 02475421 | SANDOZ SILODOSIN | SANDOZ CANADA INCORPORATED | Capsule | SILODOSIN 4 MG | Marketed |
| 02475448 | SANDOZ SILODOSIN | SANDOZ CANADA INCORPORATED | Capsule | SILODOSIN 8 MG | Marketed |
| 02565986 | SILODOSIN | SANIS HEALTH INC | Capsule | SILODOSIN 8 MG | Approved |
| 02565978 | SILODOSIN | SANIS HEALTH INC | Capsule | SILODOSIN 4 MG | Approved |
| 02361663 | RAPAFLO | ALLERGAN INC | Capsule | SILODOSIN 4 MG | Cancelled Post Market |
| 02361671 | RAPAFLO | ALLERGAN INC | Capsule | SILODOSIN 8 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 31595 | 2023-09-12 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Manufacturers |
International API supply for SILODOSIN
18 active FDA Drug Master Files.
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