TARO-CYPROTERONE/ETHINYL ESTRADIOL DIN 02425017
Health Canada record
| Active ingredient(s) | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03HB01 CYPROTERONE AND ESTROGEN |
| Original market date | 26-Mar-2015 |
| Current status date | 05-Aug-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sun Pharma Canada Inc. — licence 3-002572, currently licensed, last inspection rating C (2026-06-15).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CYPROTERONE ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02564424 | AMB-CYPROTERONE ACETATE / ETHINYL ESTRADIOL | AMBICARE PHARMACEUTICALS INC. | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 00704431 | ANDROCUR | AMDIPHARM LIMITED | Tablet | CYPROTERONE ACETATE 50 MG | Marketed |
| 02436736 | CLÉO -35 | ALTIUS HEALTHCARE INC | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02290308 | CYESTRA-35 | KNIGHT THERAPEUTICS INC. | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02245898 | CYPROTERONE | AA PHARMA INC | Tablet | CYPROTERONE ACETATE 50 MG | Marketed |
| 02233542 | DIANE-35 | BAYER INC | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 35 MCG | Marketed |
| 02390760 | MED-CYPROTERONE | GENERIC MEDICAL PARTNERS INC | Tablet | CYPROTERONE ACETATE 50 MG | Marketed |
| 02395797 | RIVA-CYPROTERONE | LABORATOIRE RIVA INC. | Tablet | CYPROTERONE ACETATE 50 MG | Marketed |
| 02309556 | TEVA-CYPROTERONE / ETHINYL ESTRADIOL | TEVA CANADA LIMITED | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG | Marketed |
| 02229449 | ALTI-CPA | ALTIMED PHARMA INC. | Tablet | CYPROTERONE ACETATE 50 MG | Cancelled Post Market |
| 00704423 | ANDROCUR DEPOT | AMDIPHARM LIMITED | Solution | CYPROTERONE ACETATE 100 MG | Cancelled Post Market |
| 02237253 | CYPROTERONE | BDH INC. | Tablet | CYPROTERONE ACETATE 50 MG | Cancelled Post Market |
| 02229723 | MYLAN-CYPROTERONE | MYLAN PHARMACEUTICALS ULC | Tablet | CYPROTERONE ACETATE 50 MG | Cancelled Post Market |
| 02491257 | MYLAN-CYPROTERONE / ETHINYLESTRADIOL | MYLAN PHARMACEUTICALS ULC | Tablet | CYPROTERONE ACETATE 2 MG; ETHINYL ESTRADIOL 0.035 MG | Cancelled Pre Market |
| 02232872 | NOVO-CYPROTERONE | NOVOPHARM LIMITED | Tablet | CYPROTERONE ACETATE 50 MG | Cancelled Post Market |
| 02242127 | RIVA-CYPROTERONE 50 MG | LABORATOIRE RIVA INC. | Tablet | CYPROTERONE ACETATE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23995 | 2020-08-05 | Abbreviated New Drug Submission (ANDS) | Administrative: Manufacturer and Product Name Change |
| 15604 | 2014-05-15 | Abbreviated New Drug Submission (ANDS) |
International API supply for CYPROTERONE ACETATE
5 valid EDQM Certificates of Suitability from 5 holders. 1 active FDA Drug Master Files.
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