APO-FENTANYL MATRIX DIN 02314657
Health Canada record
| Active ingredient(s) | FENTANYL 75 MCG |
|---|---|
| Dosage form | Patch |
| Route | Transdermal |
| Schedule | NARCOTICS (CDSA I) |
| Class | Human |
| ATC | N02AB03 FENTANYL |
| Original market date | 13-May-2009 |
| Current status date | 12-Jul-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 FENTANYL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02327112 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 12 MCG | Marketed |
| 02327163 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 100 MCG | Marketed |
| 02327155 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 75 MCG | Marketed |
| 02327147 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 50 MCG | Marketed |
| 02327139 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 37 MCG | Marketed |
| 02327120 | SANDOZ FENTANYL PATCH | SANDOZ CANADA INCORPORATED | Patch | FENTANYL 25 MCG | Marketed |
| 02282941 | TEVA-FENTANYL | TEVA CANADA LIMITED | Patch | FENTANYL 25 MCG | Marketed |
| 02282984 | TEVA-FENTANYL | TEVA CANADA LIMITED | Patch | FENTANYL 100 MCG | Marketed |
| 02282976 | TEVA-FENTANYL | TEVA CANADA LIMITED | Patch | FENTANYL 75 MCG | Marketed |
| 02282968 | TEVA-FENTANYL | TEVA CANADA LIMITED | Patch | FENTANYL 50 MCG | Marketed |
| 02311925 | TEVA-FENTANYL | TEVA CANADA LIMITED | Patch | FENTANYL 12 MCG | Marketed |
| 02314649 | APO-FENTANYL MATRIX | APOTEX INC | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02314630 | APO-FENTANYL MATRIX | APOTEX INC | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02314665 | APO-FENTANYL MATRIX | APOTEX INC | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02386852 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02386895 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02386887 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02386879 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02386860 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 37 MCG | Cancelled Pre Market |
| 02386844 | CO FENTANYL | COBALT PHARMACEUTICALS COMPANY | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 02275856 | DURAGESIC | JANSSEN INC | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02275848 | DURAGESIC | JANSSEN INC | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02275821 | DURAGESIC | JANSSEN INC | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02275813 | DURAGESIC | JANSSEN INC | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02334186 | DURAGESIC | JANSSEN INC | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 01937413 | DURAGESIC 100 | JANSSEN INC | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02280345 | DURAGESIC 12 | JANSSEN INC | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 01937383 | DURAGESIC 25 | JANSSEN INC | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 01937391 | DURAGESIC 50 | JANSSEN INC | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 01937405 | DURAGESIC 75 | JANSSEN INC | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02395657 | FENTANYL PATCH | PRO DOC LIMITEE | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 02395703 | FENTANYL PATCH | PRO DOC LIMITEE | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02395681 | FENTANYL PATCH | PRO DOC LIMITEE | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02395673 | FENTANYL PATCH | PRO DOC LIMITEE | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02395665 | FENTANYL PATCH | PRO DOC LIMITEE | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02304155 | FENTANYL TRANSDERMAL SYSTEM 100 | ACTAVIS GROUP PTC EHF | Patch (Extended-Release) | FENTANYL 100 MCG | Cancelled Pre Market |
| 02304120 | FENTANYL TRANSDERMAL SYSTEM 25 | ACTAVIS GROUP PTC EHF | Patch (Extended-Release) | FENTANYL 25 MCG | Cancelled Pre Market |
| 02304139 | FENTANYL TRANSDERMAL SYSTEM 50 | ACTAVIS GROUP PTC EHF | Patch (Extended-Release) | FENTANYL 50 MCG | Cancelled Pre Market |
| 02304147 | FENTANYL TRANSDERMAL SYSTEM 75 | ACTAVIS GROUP PTC EHF | Patch (Extended-Release) | FENTANYL 75 MCG | Cancelled Pre Market |
| 02396718 | MYLAN-FENTANYL MATRIX PATCH | MYLAN PHARMACEUTICALS ULC | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02396696 | MYLAN-FENTANYL MATRIX PATCH | MYLAN PHARMACEUTICALS ULC | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 02376806 | PAT-FENTANYL MAT | PATRIOT A DIVISION OF JANSSEN INC | Patch | FENTANYL 100 MCG | Cancelled Pre Market |
| 02376768 | PAT-FENTANYL MAT | PATRIOT A DIVISION OF JANSSEN INC | Patch | FENTANYL 12.0 MCG | Cancelled Pre Market |
| 02376776 | PAT-FENTANYL MAT | PATRIOT A DIVISION OF JANSSEN INC | Patch | FENTANYL 25 MCG | Cancelled Pre Market |
| 02376784 | PAT-FENTANYL MAT | PATRIOT A DIVISION OF JANSSEN INC | Patch | FENTANYL 50 MCG | Cancelled Pre Market |
| 02376792 | PAT-FENTANYL MAT | PATRIOT A DIVISION OF JANSSEN INC | Patch | FENTANYL 75 MCG | Cancelled Pre Market |
| 02341409 | PMS-FENTANYL MTX | PHARMASCIENCE INC | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02341395 | PMS-FENTANYL MTX | PHARMASCIENCE INC | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02341387 | PMS-FENTANYL MTX | PHARMASCIENCE INC | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02341379 | PMS-FENTANYL MTX | PHARMASCIENCE INC | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 02341417 | PMS-FENTANYL MTX | PHARMASCIENCE INC | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02330121 | RAN-FENTANYL MATRIX PATCH | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 50 MCG | Cancelled Post Market |
| 02330105 | RAN-FENTANYL MATRIX PATCH | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 12 MCG | Cancelled Post Market |
| 02330156 | RAN-FENTANYL MATRIX PATCH | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 100 MCG | Cancelled Post Market |
| 02330148 | RAN-FENTANYL MATRIX PATCH | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 75 MCG | Cancelled Post Market |
| 02330113 | RAN-FENTANYL MATRIX PATCH | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 25 MCG | Cancelled Post Market |
| 02249421 | RAN-FENTANYL TRANSDERMAL SYSTEM | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 7.5 MG | Cancelled Post Market |
| 02249448 | RAN-FENTANYL TRANSDERMAL SYSTEM | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 10 MG | Cancelled Post Market |
| 02249413 | RAN-FENTANYL TRANSDERMAL SYSTEM | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 5 MG | Cancelled Post Market |
| 02249391 | RAN-FENTANYL TRANSDERMAL SYSTEM | RANBAXY PHARMACEUTICALS CANADA INC. | Patch | FENTANYL 2.5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 14123 | 2013-02-15 | Abbreviated New Drug Submission (ANDS) | Manufacturer and product name change |
| 14027 | 2013-01-17 | Abbreviated New Drug Submission (ANDS) | Manufacturer and product name change |
| 9733 | 2008-08-25 | Abbreviated New Drug Submission (ANDS) |
International API supply for FENTANYL
12 valid EDQM Certificates of Suitability from 12 holders. 11 active FDA Drug Master Files.
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