FLEXERIL DIN 02495422
Health Canada record
| Active ingredient(s) | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M03BX08 CYCLOBENZAPRINE |
| Original market date | 20-Mar-2020 |
| Current status date | 05-Jul-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Orimed Pharma Inc — licence 102094, currently licensed, last inspection rating C (2025-01-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CYCLOBENZAPRINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02485419 | AG-CYCLOBENZAPRINE | ANGITA PHARMA INC. | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02177145 | APO-CYCLOBENZAPRINE | APOTEX INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02348853 | AURO-CYCLOBENZAPRINE | AURO PHARMA INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02171848 | CYCLOBENZAPRINE | APOTEX INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Approved |
| 02287064 | CYCLOBENZAPRINE | SANIS HEALTH INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02424584 | CYCLOBENZAPRINE | SIVEM PHARMACEUTICALS ULC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02357127 | JAMP-CYCLOBENZAPRINE | JAMP PHARMA CORPORATION | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02212048 | PMS-CYCLOBENZAPRINE - TAB 10MG | PHARMASCIENCE INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02220644 | PRO-CYCLOBENZAPRINE | PRO DOC LIMITEE | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02242079 | RIVA-CYCLOBENZAPRINE | LABORATOIRE RIVA INC. | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02080052 | TEVA-CYCLOBENZAPRINE | TEVA CANADA LIMITED | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Marketed |
| 02174618 | ALTI-CYCLOBENZAPRINE - TAB 10MG | ALTIMED PHARMA INC. | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02363690 | AVA-CYCLOBENZAPRINE | AVANSTRA INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02325195 | CYCLOBENZAPRINE | SORRES PHARMA INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02238633 | DOM-CYCLOBENZAPRINE | DOMINION PHARMACAL | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00782742 | FLEXERIL -(10MG) | JANSSEN INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02357089 | JAMP-CYCLOBENZAPRINE | JAMP PHARMA CORPORATION | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Pre Market |
| 02231353 | MYLAN-CYCLOBENZAPRINE | MYLAN PHARMACEUTICALS ULC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02249359 | PHL-CYCLOBENZAPRINE | PHARMEL INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02370913 | Q-CYCLOBENZAPRINE | QD PHARMACEUTICALS ULC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02236506 | RATIO-CYCLOBENZAPRINE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02383578 | ZYM-CYCLOBENZAPRINE | ZYMCAN PHARMACEUTICALS INC | Tablet | CYCLOBENZAPRINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23085 | 2020-01-07 | Abbreviated New Drug Submission (ANDS) | NEW LABELLING AND ADMINISTRATIVE LICENSING AGREEMENT BETWEEN TWO COMPANIES |
International API supply for CYCLOBENZAPRINE HYDROCHLORIDE
6 active FDA Drug Master Files.
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