DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28 DIN 02424460
Health Canada record
| Active ingredient(s) | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03AA12 DROSPIRENONE AND ESTROGEN |
| Original market date | |
| Current status date | 13-Feb-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DROSPIRENONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02268825 | ANGELIQ | BAYER INC | Tablet | DROSPIRENONE 1.0 MG; ESTRADIOL 1.0 MG | Marketed |
| 02462060 | DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.02 MG | Marketed |
| 02421437 | DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 21 | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02421445 | DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 28 | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02415380 | MYA | APOTEX INC | Tablet | DROSPIRENONE 3.00 MG; ETHINYL ESTRADIOL 0.02 MG | Marketed |
| 02416492 | NIKKI | LUPIN LIMITED | Tablet | DROSPIRENONE 3.0 MG; ETHINYL ESTRADIOL 0.02 MG | Approved |
| 02416506 | QISMETTE 21 | LUPIN LIMITED | Tablet | DROSPIRENONE 3.0 MG; ETHINYL ESTRADIOL 0.030 MG | Approved |
| 02416514 | QISMETTE 28 | LUPIN LIMITED | Tablet | DROSPIRENONE 3.0 MG; ETHINYL ESTRADIOL 0.030 MG | Approved |
| 02522802 | SLYND | DUCHESNAY INC | Tablet | DROSPIRENONE 4 MG | Marketed |
| 02261731 | YASMIN 28 | BAYER INC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02321157 | YAZ | BAYER INC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.02 MG | Marketed |
| 02387433 | YAZ PLUS | BAYER INC | Tablet | DROSPIRENONE 3.00 MG; ETHINYL ESTRADIOL 0.02 MG; LEVOMEFOLATE CALCIUM 0.451 MG; LEVOMEFOLATE CALCIUM 0.451 MG | Marketed |
| 02410788 | ZAMINE 21 | APOTEX INC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02410796 | ZAMINE 28 | APOTEX INC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02425726 | DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS | MYLAN PHARMACEUTICALS ULC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.02 MG | Cancelled Pre Market |
| 02424452 | DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 21 | MYLAN PHARMACEUTICALS ULC | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Pre Market |
| 02404575 | VESTURA | COBALT PHARMACEUTICALS COMPANY | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.02 MG | Cancelled Pre Market |
| 02442744 | YASMIN PLUS | BAYER INC | Tablet | DROSPIRENONE 3.0 MG; ETHINYL ESTRADIOL 0.03 MG; LEVOMEFOLATE CALCIUM 0.451 MG; LEVOMEFOLATE CALCIUM 0.451 MG | Cancelled Pre Market |
| 02385058 | ZARAH 21 | COBALT PHARMACEUTICALS COMPANY | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
| 02385066 | ZARAH 28 | COBALT PHARMACEUTICALS COMPANY | Tablet | DROSPIRENONE 3 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20233 | 2018-01-04 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 18719 | 2016-11-30 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 15568 | 2014-05-02 | Abbreviated New Drug Submission (ANDS) |
International API supply for DROSPIRENONE
6 valid EDQM Certificates of Suitability from 6 holders. 11 active FDA Drug Master Files.
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