HP-PAC DIN 02238525
Health Canada record
| Active ingredient(s) | LANSOPRAZOLE 30 MG; AMOXICILLIN 500 MG; CLARITHROMYCIN 500 MG |
|---|---|
| Dosage form | Tablet; Capsule; Capsule (Delayed-Release); Kit |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A02BD07 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN |
| Original market date | 18-Aug-1998 |
| Current status date | 08-Mar-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Takeda Pharmaceutical Company Limited — licence , not currently licensed, last inspection rating C (2023-12-11).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LANSOPRAZOLE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02470780 | AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN | AA PHARMA INC | Kit; Capsule; Capsule (Delayed-Release); Tablet | LANSOPRAZOLE 30 MG; AMOXICILLIN 500 MG; CLARITHROMYCIN 500 MG | Marketed |
| 02293838 | APO-LANSOPRAZOLE | APOTEX INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02293811 | APO-LANSOPRAZOLE | APOTEX INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02357682 | LANSOPRAZOLE | SANIS HEALTH INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02385767 | LANSOPRAZOLE | SIVEM PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02410389 | LANSOPRAZOLE | SIVEM PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02357690 | LANSOPRAZOLE | SANIS HEALTH INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02569558 | LANSOPRAZOLE FDT | SANIS HEALTH INC | Tablet (Delayed-Release) | LANSOPRAZOLE 15 MG | Approved |
| 02569566 | LANSOPRAZOLE FDT | SANIS HEALTH INC | Tablet (Delayed-Release) | LANSOPRAZOLE 30 MG | Approved |
| 02353849 | MYLAN-LANSOPRAZOLE | MYLAN PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02353830 | MYLAN-LANSOPRAZOLE | MYLAN PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02392410 | MYLAN-LANSOPRAZOLE FDT | MYLAN PHARMACEUTICALS ULC | Tablet (Delayed-Release) | LANSOPRAZOLE 30 MG | Approved |
| 02392402 | MYLAN-LANSOPRAZOLE FDT | MYLAN PHARMACEUTICALS ULC | Tablet (Delayed-Release) | LANSOPRAZOLE 15 MG | Approved |
| 02561247 | NB-LANSOPRAZOLE | NB PHARMA INC. | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02561239 | NB-LANSOPRAZOLE | NB PHARMA INC. | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02165503 | PREVACID | TAKEDA PHARMACEUTICALS AMERICA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02165511 | PREVACID | TAKEDA PHARMACEUTICALS AMERICA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02249464 | PREVACID FASTAB | TAKEDA PHARMACEUTICALS AMERICA INC | Tablet (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02249472 | PREVACID FASTAB | TAKEDA PHARMACEUTICALS AMERICA INC | Tablet (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02366282 | PRO-LANSOPRAZOLE | PRO DOC LIMITEE | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02366274 | PRO-LANSOPRAZOLE | PRO DOC LIMITEE | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Approved |
| 02385643 | SANDOZ LANSOPRAZOLE | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02385651 | SANDOZ LANSOPRAZOLE | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02402629 | TARO-LANSOPRAZOLE | SUN PHARMA CANADA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02402610 | TARO-LANSOPRAZOLE | SUN PHARMA CANADA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02280515 | TEVA-LANSOPRAZOLE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Marketed |
| 02280523 | TEVA-LANSOPRAZOLE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Marketed |
| 02367815 | AVA-LANSOPRAZOLE | AVANSTRA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled (Unreturned Annual) |
| 02367823 | AVA-LANSOPRAZOLE | AVANSTRA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled (Unreturned Annual) |
| 02414767 | DOM-LANSOPRAZOLE | DOMINION PHARMACAL | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled Pre Market |
| 02414775 | DOM-LANSOPRAZOLE | DOMINION PHARMACAL | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Post Market |
| 02433028 | LANSOPRAZOLE | PHARMASCIENCE INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Dormant |
| 02433672 | LANSOPRAZOLE | DOMINION PHARMACAL | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Pre Market |
| 02433001 | LANSOPRAZOLE | PHARMASCIENCE INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Dormant |
| 02410370 | LANSOPRAZOLE-15 | SIVEM PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled Post Market |
| 02385775 | LANSOPRAZOLE-30 | SIVEM PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Post Market |
| 02489813 | M-LANSOPRAZOLE | MANTRA PHARMA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Post Market |
| 02489805 | M-LANSOPRAZOLE | MANTRA PHARMA INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled Post Market |
| 02354764 | NTP-LANSOPRAZOLE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Pre Market |
| 02354756 | NTP-LANSOPRAZOLE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled Pre Market |
| 02395258 | PMS-LANSOPRAZOLE | PHARMASCIENCE INC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Dormant |
| 02395266 | PMS-LANSOPRAZOLE | PHARMASCIENCE INC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Dormant |
| 02369028 | Q-LANSOPRAZOLE | QD PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Cancelled Post Market |
| 02369001 | Q-LANSOPRAZOLE | QD PHARMACEUTICALS ULC | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Cancelled Pre Market |
| 02422816 | RIVA-LANSOPRAZOLE | LABORATOIRE RIVA INC. | Capsule (Delayed-Release) | LANSOPRAZOLE 30 MG | Dormant |
| 02422808 | RIVA-LANSOPRAZOLE | LABORATOIRE RIVA INC. | Capsule (Delayed-Release) | LANSOPRAZOLE 15 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18786 | 2016-12-13 | Supplement to a New Drug Submission (SNDS) | UPDATE TO THE LABELLING OF THE SAFETY INFORMATION WITH RESPECT TO INTERACTION WITH ANTIRETROVIRAL PRODUCTS |
| 9816 | 2008-10-09 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 2675 | 1998-07-30 | New Drug Submission (NDS) |
International API supply for LANSOPRAZOLE
17 valid EDQM Certificates of Suitability from 17 holders. 47 active FDA Drug Master Files.
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