LUTERA 28 DIN 02401207
Health Canada record
| Active ingredient(s) | LEVONORGESTREL 100.0 MCG; ETHINYL ESTRADIOL 20.0 MCG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03AA07 LEVONORGESTREL AND ESTROGEN |
| Original market date | 18-Jun-2013 |
| Current status date | 22-Jun-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cobalt Pharmaceuticals Company — licence 100618, not currently licensed, last inspection rating C (2018-11-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LEVONORGESTREL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02236974 | ALESSE 21 | PFIZER CANADA ULC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02236975 | ALESSE 28 | PFIZER CANADA ULC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02387875 | ALYSENA 21 | APOTEX INC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02387883 | ALYSENA 28 | APOTEX INC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02532174 | AUDRINA 21 | JAMP PHARMA CORPORATION | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02532182 | AUDRINA 28 | JAMP PHARMA CORPORATION | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02298538 | AVIANE 21 | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02298546 | AVIANE 28 | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02433532 | BACKUP PLAN ONESTEP | APOTEX INC | Tablet | LEVONORGESTREL 1.5 MG | Marketed |
| 02425009 | CONTINGENCY ONE | SENADOR LABORATORIES PRIVATE LIMITED | Tablet | LEVONORGESTREL 1.5 MG | Marketed |
| 02398869 | INDAYO | SENADOR LABORATORIES PRIVATE LIMITED | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02459523 | KYLEENA | BAYER INC | Insert (Extended-Release) | LEVONORGESTREL 19.5 MG | Marketed |
| 02424282 | LAYLAA 21 | LUPIN PHARMA CANADA LIMITED | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02424290 | LAYLAA 28 | LUPIN PHARMA CANADA LIMITED | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Marketed |
| 02042320 | MIN-OVRAL 21 | PFIZER CANADA ULC | Tablet | LEVONORGESTREL 150 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 02042339 | MIN-OVRAL 28 | PFIZER CANADA ULC | Tablet | LEVONORGESTREL 150 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 02243005 | MIRENA | BAYER INC | Insert (Extended-Release) | LEVONORGESTREL 52 MG | Marketed |
| 02548461 | MYSTEP | JAMP PHARMA CORPORATION | Tablet | LEVONORGESTREL 1.5 MG | Marketed |
| 02322919 | NORLEVO | LABORATOIRE HRA PHARMA | Tablet | LEVONORGESTREL 1.5 MG | Approved |
| 02387085 | OVIMA 21 | APOTEX INC | Tablet | LEVONORGESTREL 150 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 02387093 | OVIMA 28 | APOTEX INC | Tablet | LEVONORGESTREL 150 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 02293854 | PLAN B | FOUNDATION CONSUMER HEALTHCARE, LLC | Tablet | LEVONORGESTREL 1.5 MG | Marketed |
| 02295946 | PORTIA 21 | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02295954 | PORTIA 28 | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02426927 | QUATERNA | MYLAN PHARMACEUTICALS ULC | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG; ETHINYL ESTRADIOL 0.01 MG | Approved |
| 02296659 | SEASONALE | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02346176 | SEASONIQUE | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG; ETHINYL ESTRADIOL 0.01 MG | Marketed |
| 00707600 | TRIQUILAR 21 | BAYER INC | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 00707503 | TRIQUILAR 28 | BAYER INC | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Marketed |
| 02430177 | BACKUP PLAN | APOTEX INC | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Pre Market |
| 02410230 | CONTINGENCY | JAI PHARMA LIMITED | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Pre Market |
| 02388138 | ESME 21 | MYLAN PHARMACEUTICALS ULC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Cancelled Post Market |
| 02388146 | ESME 28 | MYLAN PHARMACEUTICALS ULC | Tablet | LEVONORGESTREL 100 MCG; ETHINYL ESTRADIOL 20 MCG | Cancelled Post Market |
| 02408295 | JAYDESS | BAYER INC | Insert (Extended-Release) | LEVONORGESTREL 13.5 MG | Cancelled Post Market |
| 02431033 | LEVONORGESTREL TABLETS, 0.75MG | LUPIN LIMITED | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Pre Market |
| 02401185 | LUTERA 21 | COBALT PHARMACEUTICALS COMPANY | Tablet | LEVONORGESTREL 100.0 MCG; ETHINYL ESTRADIOL 20.0 MCG | Cancelled Post Market |
| 00782432 | MIN-OVRAL 21 TAB | WYETH LTD. | Tablet | LEVONORGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
| 02364905 | NEXT CHOICE | ACTAVIS PHARMA COMPANY | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Post Market |
| 02285576 | NORLEVO | LABORATOIRE HRA PHARMA | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Post Market |
| 02060590 | NORPLANT SYSTEM KIT 36MG/IMPLANT | WYETH-AYERST CANADA INC. | Implant | LEVONORGESTREL 36 MG | Cancelled Post Market |
| 02371189 | OPTION 2 | PERRIGO INTERNATIONAL | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Post Market |
| 02241674 | PLAN B | FOUNDATION CONSUMER HEALTHCARE, LLC | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Post Market |
| 02239806 | PREVEN EMERGENCY CONTRACEPTIVE | GYNÉTICS LTD/LTÉE | Tablet | LEVONORGESTREL 0.25 MG; ETHINYL ESTRADIOL 0.05 MG | Cancelled (Unreturned Annual) |
| 02240544 | PREVEN TABLETS | SHIRE PHARMA CANADA ULC | Tablet | LEVONORGESTREL 0.25 MG; ETHINYL ESTRADIOL 0.05 MG | Cancelled Post Market |
| 02367874 | TEVA-LEVONORGESTREL | TEVA CANADA LIMITED | Tablet | LEVONORGESTREL 0.75 MG | Cancelled Pre Market |
| 02043726 | TRIPHASIL 21 | WYETH CANADA | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Cancelled Post Market |
| 00782416 | TRIPHASIL 21 TAB | WYETH LTD. | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Cancelled Post Market |
| 02043734 | TRIPHASIL 28 | WYETH CANADA | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Cancelled Post Market |
| 00782424 | TRIPHASIL 28 TAB | WYETH LTD. | Tablet | LEVONORGESTREL 50 MCG; ETHINYL ESTRADIOL 30 MCG; LEVONORGESTREL 75 MCG; ETHINYL ESTRADIOL 40 MCG; LEVONORGESTREL 125 MCG; ETHINYL ESTRADIOL 30 MCG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 14066 | 2013-02-08 | Abbreviated New Drug Submission (ANDS) |
International API supply for LEVONORGESTREL
4 valid EDQM Certificates of Suitability from 4 holders. 15 active FDA Drug Master Files.
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