LUPIN-ESTRADIOL DIN 02449056
Status: Marketed
Holder: LUPIN PHARMA CANADA LIMITED
Molecule: ESTRADIOL (ESTRADIOL HEMIHYDRATE)
Available to quote
Health Canada record
| Active ingredient(s) | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 1 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03CA03 ESTRADIOL |
| Original market date | 29-Feb-2016 |
| Current status date | 29-Feb-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Lupin Pharma Canada Limited — licence 102119, currently licensed, last inspection rating C (2025-07-22).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ESTRADIOL (ESTRADIOL HEMIHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02505223 | BIJUVA | KNIGHT THERAPEUTICS INC. | Capsule | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 1 MG; PROGESTERONE 100 MG | Marketed |
| 02505215 | BIJUVA | KNIGHT THERAPEUTICS INC. | Capsule | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.5 MG; PROGESTERONE 100 MG | Approved |
| 02247499 | CLIMARA 25 | BAYER INC | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 25 MCG | Marketed |
| 02231509 | CLIMARA 50 | BAYER INC | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 50 MCG | Marketed |
| 02247500 | CLIMARA 75 | BAYER INC | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 75 MCG | Marketed |
| 02238704 | ESTROGEL | ORGANON CANADA INC. | Gel | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.06 % | Marketed |
| 02503697 | IMVEXXY | KNIGHT THERAPEUTICS INC. | Insert | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10 MCG | Marketed |
| 02503689 | IMVEXXY | KNIGHT THERAPEUTICS INC. | Insert | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 4 MCG | Marketed |
| 02449048 | LUPIN-ESTRADIOL | LUPIN PHARMA CANADA LIMITED | Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.5 MG | Marketed |
| 02449064 | LUPIN-ESTRADIOL | LUPIN PHARMA CANADA LIMITED | Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 2 MG | Marketed |
| 02542013 | PMS-ESTRADIOL 10 | PHARMASCIENCE INC | Vaginal Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10 MCG | Approved |
| 02246969 | SANDOZ ESTRADIOL DERM 100 | SANDOZ CANADA INCORPORATED | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100 MCG | Marketed |
| 02246967 | SANDOZ ESTRADIOL DERM 50 | SANDOZ CANADA INCORPORATED | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 50 MCG | Marketed |
| 02246968 | SANDOZ ESTRADIOL DERM 75 | SANDOZ CANADA INCORPORATED | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 75 MCG | Marketed |
| 02570777 | SPC-ESTRADIOL 10 | SUN PHARMA CANADA INC | Vaginal Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10 MCG | Approved |
| 02325462 | VAGIFEM 10 | NOVO NORDISK CANADA INC | Vaginal Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10 MCG | Marketed |
| 02231510 | CLIMARA 100 | BAYER INC | Patch | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100 MCG | Cancelled Post Market |
| 02403404 | ESTROGEL PROPAK | MERCK CANADA INC | Metered-Dose Pump; Capsule | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.06 %; PROGESTERONE 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17472 | 2015-11-16 | Abbreviated New Drug Submission (ANDS) |