PMS-BACLOFEN DIN 02063735
Health Canada record
| Active ingredient(s) | BACLOFEN 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M03BX01 BACLOFEN |
| Original market date | 31-Dec-1994 |
| Current status date | 31-Dec-1994 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pharmascience Inc. — licence 100241, currently licensed, last inspection rating C (2025-03-20).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BACLOFEN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02139391 | APO-BACLOFEN | APOTEX INC | Tablet | BACLOFEN 20 MG | Marketed |
| 02139332 | APO-BACLOFEN | APOTEX INC | Tablet | BACLOFEN 10 MG | Marketed |
| 02287021 | BACLOFEN | SANIS HEALTH INC | Tablet | BACLOFEN 10 MG | Marketed |
| 02544679 | BACLOFEN | SIVEM PHARMACEUTICALS ULC | Tablet | BACLOFEN 20 MG | Marketed |
| 02544660 | BACLOFEN | SIVEM PHARMACEUTICALS ULC | Tablet | BACLOFEN 10 MG | Marketed |
| 02287048 | BACLOFEN | SANIS HEALTH INC | Tablet | BACLOFEN 20 MG | Marketed |
| 02413647 | BACLOFEN INJECTION | STERIMAX INC | Solution | BACLOFEN 10 MG | Marketed |
| 02413620 | BACLOFEN INJECTION | STERIMAX INC | Solution | BACLOFEN 0.05 MG | Marketed |
| 02413639 | BACLOFEN INJECTION | STERIMAX INC | Solution | BACLOFEN 10 MG | Marketed |
| 02457075 | BACLOFEN INJECTION | HIKMA CANADA LIMITED | Solution | BACLOFEN 2 MG | Marketed |
| 02553341 | BACLOFEN INJECTION USP | JAMP PHARMA CORPORATION | Solution | BACLOFEN 2 MG | Marketed |
| 02485516 | BACLOFEN INTRATHECAL | AVIR PHARMA INC. | Solution | BACLOFEN 2 MG | Marketed |
| 02485508 | BACLOFEN INTRATHECAL | AVIR PHARMA INC. | Solution | BACLOFEN 0.5 MG | Marketed |
| 02544482 | JAMP BACLOFEN | JAMP PHARMA CORPORATION | Tablet | BACLOFEN 10 MG | Marketed |
| 02544490 | JAMP BACLOFEN | JAMP PHARMA CORPORATION | Tablet | BACLOFEN 20 MG | Marketed |
| 02542609 | MINT-BACLOFEN | MINT PHARMACEUTICALS INC | Tablet | BACLOFEN 20 MG | Approved |
| 02542595 | MINT-BACLOFEN | MINT PHARMACEUTICALS INC | Tablet | BACLOFEN 10 MG | Approved |
| 02088401 | MYLAN-BACLOFEN | MYLAN PHARMACEUTICALS ULC | Tablet | BACLOFEN 20 MG | Marketed |
| 02088398 | MYLAN-BACLOFEN | MYLAN PHARMACEUTICALS ULC | Tablet | BACLOFEN 10 MG | Marketed |
| 02063743 | PMS-BACLOFEN | PHARMASCIENCE INC | Tablet | BACLOFEN 20 MG | Marketed |
| 02152592 | PRO-BACLOFEN | PRO DOC LIMITEE | Tablet | BACLOFEN 20 MG | Marketed |
| 02152584 | PRO-BACLOFEN | PRO DOC LIMITEE | Tablet | BACLOFEN 10 MG | Marketed |
| 02242151 | RIVA-BACLOFEN | LABORATOIRE RIVA INC. | Tablet | BACLOFEN 20 MG | Marketed |
| 02242150 | RIVA-BACLOFEN | LABORATOIRE RIVA INC. | Tablet | BACLOFEN 10 MG | Marketed |
| 02371421 | AVA-BACLOFEN | AVANSTRA INC | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02371413 | AVA-BACLOFEN | AVANSTRA INC | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02136090 | BACLOFEN | APOTEX INC | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02136104 | BACLOFEN | APOTEX INC | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02457067 | BACLOFEN INJECTION | HIKMA CANADA LIMITED | Solution | BACLOFEN 0.5 MG | Dormant |
| 02457059 | BACLOFEN INJECTION | HIKMA CANADA LIMITED | Solution | BACLOFEN 0.05 MG | Dormant |
| 02485494 | BACLOFEN INTRATHECAL | AVIR PHARMA INC. | Solution | BACLOFEN 0.05 MG | Dormant |
| 02147556 | BACLOFEN TABLETS - 10MG | BDH INC. | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02147564 | BACLOFEN TABLETS - 20MG | BDH INC. | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02230033 | BACLOFEN TABLETS 10MG | PREMPHARM INC | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02230034 | BACLOFEN TABLETS 20MG | PREMPHARM INC | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02244644 | CO BACLOFEN TABLETS 10MG | COBALT PHARMACEUTICALS COMPANY | Tablet | BACLOFEN 10 MG | Cancelled Pre Market |
| 02244645 | CO BACLOFEN TABLETS 20MG | COBALT PHARMACEUTICALS COMPANY | Tablet | BACLOFEN 20 MG | Cancelled Pre Market |
| 02138271 | DOM-BACLOFEN-TAB 10MG | DOMINION PHARMACAL | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02138298 | DOM-BACLOFEN-TAB 20MG | DOMINION PHARMACAL | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02238445 | FTP-BACLOFEN | FTP-PHARMACAL INC. | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02238446 | FTP-BACLOFEN | FTP-PHARMACAL INC. | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 00636576 | LIORESAL D.S. TAB 20MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02131048 | LIORESAL INTRATHECAL 0.05MG/ML | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | BACLOFEN 0.05 MG | Cancelled Post Market |
| 02131056 | LIORESAL INTRATHECAL 0.5MG/ML | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | BACLOFEN 0.5 MG | Cancelled Post Market |
| 02131064 | LIORESAL INTRATHECAL 2MG/ML | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | BACLOFEN 2 MG | Cancelled Post Market |
| 00455881 | LIORESAL TAB 10MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02084449 | MED BACLOFEN TAB 10MG | MEDICAN PHARMA INCORPORATED | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02084457 | MED BACLOFEN TAB 20MG | MEDICAN PHARMA INCORPORATED | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02229937 | NOVO-BACLOFEN | NOVOPHARM LIMITED | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02229936 | NOVO-BACLOFEN | NOVOPHARM LIMITED | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02239076 | PENTA-BACLOFEN TABLETS | PENTAPHARM LTD. | Tablet | BACLOFEN 20 MG | Cancelled (Unreturned Annual) |
| 02239075 | PENTA-BACLOFEN TABLETS | PENTAPHARM LTD. | Tablet | BACLOFEN 10 MG | Cancelled (Unreturned Annual) |
| 02236963 | PHL-BACLOFEN | PHARMEL INC | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02236964 | PHL-BACLOFEN | PHARMEL INC | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02236508 | RATIO-BACLOFEN | TEVA CANADA LIMITED | Tablet | BACLOFEN 20 MG | Cancelled Post Market |
| 02236507 | RATIO-BACLOFEN | TEVA CANADA LIMITED | Tablet | BACLOFEN 10 MG | Cancelled Post Market |
| 02442140 | SANDOZ BACLOFEN | SANDOZ CANADA INCORPORATED | Tablet | BACLOFEN 10 MG | Cancelled Pre Market |
| 02442159 | SANDOZ BACLOFEN | SANDOZ CANADA INCORPORATED | Tablet | BACLOFEN 20 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 5577 | 1994-01-14 | New Drug Submission (NDS) |
International API supply for BACLOFEN
7 valid EDQM Certificates of Suitability from 7 holders. 16 active FDA Drug Master Files.
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