MAEVE DIN 02458683
Status: Marketed
Holder: GLENMARK PHARMACEUTICALS CANADA INC.
Molecule: NORETHINDRONE
Available to quote
Health Canada record
| Active ingredient(s) | NORETHINDRONE 0.35 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03AC01 NORETHISTERONE |
| Original market date | 16-Dec-2022 |
| Current status date | 16-Dec-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Glenmark Pharmaceuticals Canada Inc. — licence 102261, currently licensed, last inspection rating C (2024-05-14).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NORETHINDRONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02189054 | BREVICON 1/35 TABLETS (21-DAY PACK) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02189062 | BREVICON 1/35 TABLETS (28-DAY PACK) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02441306 | JENCYCLA | LUPIN PHARMA CANADA LIMITED | Tablet | NORETHINDRONE 0.35 MG | Marketed |
| 02410303 | MOVISSE | SENADOR LABORATORIES PRIVATE LIMITED | Tablet | NORETHINDRONE 0.35 MG | Marketed |
| 02197502 | SELECT 1/35 (21-DAY) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1.0 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02199297 | SELECT 1/35 (28-DAY) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1.0 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02187108 | SYNPHASIC 21 TABLETS | PFIZER CANADA ULC | Tablet | NORETHINDRONE 0.5 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 1.0 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02187116 | SYNPHASIC 28 TABLETS | PFIZER CANADA ULC | Tablet | NORETHINDRONE 0.5 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 1.0 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 00531006 | BREVICON 1/35 21 TAB | SYNTEX INC. | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL .035 MG | Cancelled Post Market |
| 00531014 | BREVICON 1/35 28 TAB | SYNTEX INC. | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL .035 MG | Cancelled Post Market |
| 02435659 | GENERESS | ALLERGAN INC | Tablet (Chewable) | NORETHINDRONE 0.8 MG; ETHINYL ESTRADIOL 0.025 MG | Cancelled Pre Market |
| 00037605 | MICRONOR TABLETS 28-DAY | JANSSEN INC | Tablet | NORETHINDRONE 0.35 MG | Cancelled Post Market |
| 02188724 | NORINYL 1/50 -(21-DAY REGIMEN) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1 MG; MESTRANOL .05 MG | Cancelled Post Market |
| 02188732 | NORINYL 1/50 -(28-DAY REGIMEN) | PFIZER CANADA ULC | Tablet | NORETHINDRONE 1 MG; MESTRANOL 0.05 MG | Cancelled Post Market |
| 00030333 | NORINYL 1/50 21 TAB | SYNTEX INC. | Tablet | NORETHINDRONE 1 MG; MESTRANOL .05 MG | Cancelled Post Market |
| 00340847 | NORINYL 1/50 28 TAB | SYNTEX INC. | Tablet | NORETHINDRONE 1 MG; MESTRANOL .05 MG | Cancelled Post Market |
| 00340731 | ORTHO 0.5/35 TABLETS (28 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 0.5 MG; ETHINYL ESTRADIOL 0.035 MG | Cancelled Post Market |
| 00372846 | ORTHO 1/35 TABLETS (21 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL .035 MG | Cancelled Post Market |
| 00372838 | ORTHO 1/35 TABLETS (28 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 1 MG; ETHINYL ESTRADIOL .035 MG | Cancelled Post Market |
| 00602957 | ORTHO 7/7/7 TABLETS (21 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 0.5 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 0.75 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 1 MG; ETHINYL ESTRADIOL 0.035 MG | Cancelled Post Market |
| 00602965 | ORTHO 7/7/7 TABLETS (28 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 0.5 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 0.75 MG; ETHINYL ESTRADIOL 0.035 MG; NORETHINDRONE 1 MG; ETHINYL ESTRADIOL 0.035 MG | Cancelled Post Market |
| 00022608 | ORTHO-NOVUM 1/50 TABLETS (21 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 1 MG; MESTRANOL .05 MG | Cancelled Post Market |
| 00340758 | ORTHO-NOVUM 1/50 TABLETS (28 DAY) | JANSSEN INC | Tablet | NORETHINDRONE 1 MG; MESTRANOL .05 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 28365 | 2022-06-09 | Supplement to an Abbreviated New Drug Submission (SANDS) | To update Brand Name, Product Labels and Product Monograph. Administrative: Product Name Change |
| 18623 | 2016-11-03 | Abbreviated New Drug Submission (ANDS) |
International API supply for NORETHINDRONE
14 active FDA Drug Master Files.
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