NAT-MONTELUKAST DIN 02522128
Status: Dormant
Holder: NATCO PHARMA (CANADA) INC
Molecule: MONTELUKAST (MONTELUKAST SODIUM)
Available to quote
Health Canada record
| Active ingredient(s) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG |
|---|---|
| Dosage form | Tablet (Chewable) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03DC03 MONTELUKAST |
| Original market date | 19-Dec-2022 |
| Current status date | 01-Apr-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Natco Pharma (Canada) Inc — licence 102058, currently licensed, last inspection rating C (2022-07-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MONTELUKAST (MONTELUKAST SODIUM)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02379236 | ACH-MONTELUKAST | ACCORD HEALTHCARE INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02374609 | APO-MONTELUKAST | APOTEX INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02377608 | APO-MONTELUKAST | APOTEX INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02377616 | APO-MONTELUKAST | APOTEX INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02401274 | AURO-MONTELUKAST | AURO PHARMA INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02391422 | JAMP-MONTELUKAST | JAMP PHARMA CORPORATION | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02399997 | MAR-MONTELUKAST | MARCAN PHARMACEUTICALS INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02408643 | MINT-MONTELUKAST | MINT PHARMACEUTICALS INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02408635 | MINT-MONTELUKAST | MINT PHARMACEUTICALS INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02408627 | MINT-MONTELUKAST | MINT PHARMACEUTICALS INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02379325 | MONTELUKAST | SANIS HEALTH INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02379333 | MONTELUKAST | SANIS HEALTH INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02379821 | MONTELUKAST | PRO DOC LIMITEE | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02382474 | MONTELUKAST | SIVEM PHARMACEUTICALS ULC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02382466 | MONTELUKAST | SIVEM PHARMACEUTICALS ULC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02382458 | MONTELUKAST | SIVEM PHARMACEUTICALS ULC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02379856 | MONTELUKAST | PRO DOC LIMITEE | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02379848 | MONTELUKAST | PRO DOC LIMITEE | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02354977 | PMS-MONTELUKAST | PHARMASCIENCE INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02354985 | PMS-MONTELUKAST | PHARMASCIENCE INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02373947 | PMS-MONTELUKAST FC | PHARMASCIENCE INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02398826 | RIVA-MONTELUKAST FC | LABORATOIRE RIVA INC. | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02328593 | SANDOZ MONTELUKAST | SANDOZ CANADA INCORPORATED | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02358611 | SANDOZ MONTELUKAST | SANDOZ CANADA INCORPORATED | Granules | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02330393 | SANDOZ MONTELUKAST | SANDOZ CANADA INCORPORATED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02330385 | SANDOZ MONTELUKAST | SANDOZ CANADA INCORPORATED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02243602 | SINGULAIR | ORGANON CANADA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02238216 | SINGULAIR | ORGANON CANADA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02238217 | SINGULAIR | ORGANON CANADA INC. | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02389517 | SPC-MONTELUKAST | SUN PHARMA CANADA INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02355523 | TEVA-MONTELUKAST | TEVA CANADA LIMITED | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Marketed |
| 02355507 | TEVA-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Marketed |
| 02355515 | TEVA-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Marketed |
| 02401150 | ACCEL-MONTELUKAST SODIUM TABLETS | ACCEL PHARMA INC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Pre Market |
| 02410273 | ACH-MONTELUKAST | ACCORD HEALTHCARE INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Post Market |
| 02410265 | ACH-MONTELUKAST | ACCORD HEALTHCARE INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02376679 | DOM-MONTELUKAST | DOMINION PHARMACAL | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02376687 | DOM-MONTELUKAST | DOMINION PHARMACAL | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Post Market |
| 02376695 | DOM-MONTELUKAST FC | DOMINION PHARMACAL | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Post Market |
| 02399865 | MAR-MONTELUKAST | MARCAN PHARMACEUTICALS INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Dormant |
| 02399873 | MAR-MONTELUKAST | MARCAN PHARMACEUTICALS INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Dormant |
| 02379317 | MONTELUKAST | SANIS HEALTH INC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02380749 | MYLAN-MONTELUKAST | MYLAN PHARMACEUTICALS ULC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02380757 | MYLAN-MONTELUKAST | MYLAN PHARMACEUTICALS ULC | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Post Market |
| 02368226 | MYLAN-MONTELUKAST | MYLAN PHARMACEUTICALS ULC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Post Market |
| 02376830 | NTP-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Pre Market |
| 02376849 | NTP-MONTELUKAST | TEVA CANADA LIMITED | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Pre Market |
| 02376822 | NTP-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Pre Market |
| 02377586 | Q-MONTELUKAST | QD PHARMACEUTICALS ULC | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Pre Market |
| 02402807 | RAN-MONTELUKAST | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Post Market |
| 02402793 | RAN-MONTELUKAST | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02336677 | RATIO-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Pre Market |
| 02336669 | RATIO-MONTELUKAST | TEVA CANADA LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Pre Market |
| 02336685 | RATIO-MONTELUKAST | TEVA CANADA LIMITED | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled Pre Market |
| 02398818 | RIVA-MONTELUKAST | LABORATOIRE RIVA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled Pre Market |
| 02398796 | RIVA-MONTELUKAST | LABORATOIRE RIVA INC. | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Pre Market |
| 02247997 | SINGULAIR | ORGANON CANADA INC. | Granules | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled Post Market |
| 02396815 | UNI-MONTELUKAST | UNIMARK REMEDIES LIMITED | Tablet | MONTELUKAST (MONTELUKAST SODIUM) 10 MG | Cancelled (Unreturned Annual) |
| 02396807 | UNI-MONTELUKAST | UNIMARK REMEDIES LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 5 MG | Cancelled (Unreturned Annual) |
| 02396793 | UNI-MONTELUKAST | UNIMARK REMEDIES LIMITED | Tablet (Chewable) | MONTELUKAST (MONTELUKAST SODIUM) 4 MG | Cancelled (Unreturned Annual) |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 26984 | 2021-11-08 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Companies |