SANDOZ AMIODARONE DIN 02243836
Status: Marketed
Holder: SANDOZ CANADA INCORPORATED
Molecule: AMIODARONE HYDROCHLORIDE
Available to quote
Health Canada record
| Active ingredient(s) | AMIODARONE HYDROCHLORIDE 200 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C01BD01 AMIODARONE |
| Original market date | 21-Aug-2001 |
| Current status date | 02-Dec-2005 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AMIODARONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02568667 | AMIODARONE | SANIS HEALTH INC | Tablet | AMIODARONE HYDROCHLORIDE 100 MG | Approved |
| 02385465 | AMIODARONE | SIVEM PHARMACEUTICALS ULC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02364336 | AMIODARONE | SANIS HEALTH INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02242325 | AMIODARONE HYDROCHLORIDE FOR INJECTION | SANDOZ CANADA INCORPORATED | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Marketed |
| 02245248 | AMIODARONE HYDROCHLORIDE FOR INJECTION, USP | FRESENIUS KABI CANADA LTD | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Marketed |
| 02246194 | APO-AMIODARONE TABLETS | APOTEX INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02531844 | JAMP AMIODARONE | JAMP PHARMA CORPORATION | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02427346 | PENDO-AMIODARONE | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Approved |
| 02292173 | PMS-AMIODARONE | PHARMASCIENCE INC | Tablet | AMIODARONE HYDROCHLORIDE 100 MG | Marketed |
| 02242472 | PMS-AMIODARONE | PHARMASCIENCE INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02309661 | PRO-AMIODARONE - 200 | PRO DOC LIMITEE | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02552949 | RIVA-AMIODARONE | LABORATOIRE RIVA INC. | Tablet | AMIODARONE HYDROCHLORIDE 100 MG | Approved |
| 02247217 | RIVA-AMIODARONE | LABORATOIRE RIVA INC. | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02239835 | TEVA-AMIODARONE | TEVA CANADA LIMITED | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Marketed |
| 02300893 | AMIODARONE | SORRES PHARMA INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02246953 | AMIODARONE FOR INJECTION 50MG/ML | TEVA CANADA LIMITED | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02245696 | AMIODARONE HYDROCHLORIDE FOR INJECTION | PFIZER CANADA ULC | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02423227 | AMIODARONE HYDROCHLORIDE FOR INJECTION | JAMP PHARMA CORPORATION | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Dormant |
| 02388049 | AMIODARONE HYDROCHLORIDE INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02387700 | AMIODARONE HYDROCHLORIDE INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Pre Market |
| 02249502 | AMIODARONE OMEGA | OMEGA LABORATORIES LIMITED | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Pre Market |
| 02374684 | AMIODARONE SYRINGE | SANDOZ CANADA INCORPORATED | Solution | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02364263 | AVA-AMIODARONE | AVANSTRA INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02036282 | CORDARONE | PFIZER CANADA ULC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02163616 | CORDARONE INTRAVENOUS - LIQ IV 50MG/ML | WYETH-AYERST CANADA INC. | Liquid | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00705934 | CORDARONE TAB 200MG | AYERST LABORATORIES | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02294508 | DOM-AMIODARONE | DOMINION PHARMACAL | Tablet | AMIODARONE HYDROCHLORIDE 100 MG | Cancelled Pre Market |
| 02246331 | DOM-AMIODARONE | DOMINION PHARMACAL | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02240604 | MYLAN-AMIODARONE | MYLAN PHARMACEUTICALS ULC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02361280 | NTP-AMIODARONE | TEVA CANADA LIMITED | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Pre Market |
| 02336421 | NU-AMIODARONE | NU-PHARM INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled (Unreturned Annual) |
| 02294516 | PHL-AMIODARONE | PHARMEL INC | Tablet | AMIODARONE HYDROCHLORIDE 100 MG | Cancelled Pre Market |
| 02245781 | PHL-AMIODARONE | PHARMEL INC | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02240071 | RATIO-AMIODARONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | AMIODARONE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 02242612 | RATIO-AMIODARONE I.V. | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Liquid | AMIODARONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 7635 | 2005-12-01 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 905 | 2001-05-30 | Abbreviated New Drug Submission (ANDS) |
International API supply for AMIODARONE HYDROCHLORIDE
10 valid EDQM Certificates of Suitability from 10 holders. 7 active FDA Drug Master Files.
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