BUSPIRONE DIN 02207664
Health Canada record
| Active ingredient(s) | BUSPIRONE HYDROCHLORIDE 5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05BE01 BUSPIRONE |
| Original market date | |
| Current status date | 18-Dec-2020 |
| 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 BUSPIRONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02550555 | AMB-BUSPIRONE | AMBICARE PHARMACEUTICALS INC. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02500213 | AURO-BUSPIRONE | AURO PHARMA INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02207672 | BUSPIRONE | APOTEX INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Approved |
| 02513382 | BUSPIRONE HYDROCHLORIDE TABLETS, USP | STRIDES PHARMA CANADA INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Approved |
| 02568128 | BUSPIRONE TABLETS | SANIS HEALTH INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02509911 | JAMP BUSPIRONE | JAMP PHARMA CORPORATION | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02519054 | MINT-BUSPIRONE | MINT PHARMACEUTICALS INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02230942 | PMS-BUSPIRONE | PHARMASCIENCE INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02223163 | PRO-BUSPIRONE | PRO DOC LIMITEE | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02223155 | PRO-BUSPIRONE | PRO DOC LIMITEE | Tablet | BUSPIRONE HYDROCHLORIDE 5 MG | Approved |
| 02231492 | TEVA-BUSPIRONE | TEVA CANADA LIMITED | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Marketed |
| 02211076 | APO-BUSPIRONE | APOTEX INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Dormant |
| 00603821 | BUSPAR TAB 10MG | BRISTOL-MYERS SQUIBB CANADA | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02447851 | BUSPIRONE | SANIS HEALTH INC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02231034 | BUSTAB | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | BUSPIRONE HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02231035 | BUSTAB | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02262916 | CO BUSPIRONE | COBALT PHARMACEUTICALS COMPANY | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02232564 | DOM-BUSPIRONE | DOMINION PHARMACAL | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02238447 | FTP-BUSPIRONE | FTP-PHARMACAL INC. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02176122 | LINBUSPIRONE | LINSON PHARMA CO. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02230874 | MYLAN-BUSPIRONE | MYLAN PHARMACEUTICALS ULC | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02238613 | PENTA-BUSPIRONE | PENTAPHARM LTD. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled (Unreturned Annual) |
| 02230941 | PMS-BUSPIRONE | PHARMASCIENCE INC | Tablet | BUSPIRONE HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02237858 | RATIO-BUSPIRONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02242149 | RIVA-BUSPIRONE 10 MG | LABORATOIRE RIVA INC. | Tablet | BUSPIRONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 24824 | 2020-12-18 | New Drug Submission (NDS) | UPDATES TO THE PRODUCT MONOGRAPH. CHANGE IN PRODUCT OWNERSHIP |
| 4254 | 1996-01-18 | New Drug Submission (NDS) |
International API supply for BUSPIRONE HYDROCHLORIDE
7 valid EDQM Certificates of Suitability from 7 holders. 12 active FDA Drug Master Files.
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