PROMETRIUM DIN 02166704
Health Canada record
| Active ingredient(s) | PROGESTERONE 100 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03DA04 PROGESTERONE |
| Original market date | 31-Dec-1995 |
| Current status date | 18-Feb-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Organon Canada Inc. — licence 3-002674, currently licensed, last inspection rating C (2025-11-06).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PROGESTERONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02549158 | ACH-PROGESTERONE | ACCORD HEALTHCARE INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 02446820 | ACT PROGESTERONE INJECTION | TEVA CANADA LIMITED | Solution | PROGESTERONE 50 MG | Marketed |
| 02493578 | AURO-PROGESTERONE | AURO PHARMA INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 02307855 | CIDR 1380 | ZOETIS CANADA INC | Insert | PROGESTERONE 1.38 G | Marketed |
| 02353881 | CIDR 330 | ZOETIS CANADA INC | Insert | PROGESTERONE 0.35 G | Marketed |
| 02245744 | COMPONENT E-C IMPLANTS WITH TYLAN | ELANCO CANADA LIMITED | Implant | PROGESTERONE 100 MG; ESTRADIOL BENZOATE 10 MG; TYLOSIN TARTRATE 29 MG | Marketed |
| 02241013 | CRINONE | EMD SERONO, A DIVISION OF EMD INC., CANADA | Gel | PROGESTERONE 8 % | Marketed |
| 02546493 | EUGIA-PROGESTERONE | EUGIA PHARMA INC. | Capsule | PROGESTERONE 100 MG | Approved |
| 02551268 | M-PROGESTERONE | MANTRA PHARMA INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 02476576 | PMS-PROGESTERONE | PHARMASCIENCE INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 02297507 | PRID DELTA | CEVA ANIMAL HEALTH INC | Implant | PROGESTERONE 1.55 G | Marketed |
| 02516187 | PROGESTERONE | SANIS HEALTH INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 02562642 | PROGESTERONE INJECTION USP | STERIMAX INC | Solution | PROGESTERONE 50 MG | Approved |
| 02531828 | PROGESTERONE INJECTION, USP | HIKMA CANADA LIMITED | Solution | PROGESTERONE 50 MG | Marketed |
| 02463113 | REDDY-PROGESTERONE | DR. REDDY'S LABORATORIES INC | Capsule | PROGESTERONE 100 MG | Marketed |
| 00618675 | SYNOVEX C | ZOETIS CANADA INC | Implant | PROGESTERONE 100 MG; ESTRADIOL BENZOATE 10 MG | Marketed |
| 00262056 | SYNOVEX S | ZOETIS CANADA INC | Implant | PROGESTERONE 200 MG; ESTRADIOL BENZOATE 20 MG | Marketed |
| 02439913 | TEVA-PROGESTERONE | TEVA CANADA LIMITED | Capsule | PROGESTERONE 100 MG | Marketed |
| 02462818 | UTROGESTAN | BESINS HEALTHCARE SA | Capsule | PROGESTERONE 200 MG | Approved |
| 01919318 | CALF-OID IMPLANT | IVY LABORATORIES, DIVISION OF IVY ANIMAL HEALTH INC. | Implant | PROGESTERONE 100 MG; ESTRADIOL BENZOATE 10 MG | Cancelled Post Market |
| 00522090 | CENTRA PROGESTIN INJ 50MG/ML | CENTRAL SALES LIMITED | Liquid | PROGESTERONE 50 MG | Cancelled Post Market |
| 02240605 | CIDR CATTLE DEVICE (INTRAVAGINAL PROGESTERONE RELEASE DEVICE) | PFIZER CANADA INC ANIMAL HEALTH GROUP | Implant | PROGESTERONE 1.9 G | Cancelled Post Market |
| 01968335 | COMPONENT E-C IMPLANTS | ELANCO CANADA LIMITED | Implant | PROGESTERONE 100 MG; ESTRADIOL BENZOATE 10 MG | Dormant |
| 01968319 | COMPONENT E-S IMPLANTS | ELANCO CANADA LIMITED | Implant | PROGESTERONE 200 MG; ESTRADIOL BENZOATE 20 MG | Dormant |
| 02334992 | ENDOMETRIN | FERRING INC | Vaginal Tablet (Effervescent) | PROGESTERONE 100 MG | Dormant |
| 02128470 | GESTEROL IN OIL-LIQ IM 50MG/ML | GERMIPHENE CORPORATION | Liquid | PROGESTERONE 50 MG | Cancelled Post Market |
| 02515504 | INPROSUB | IBSA INSTITUT BIOCHIMIQUE SA | Solution | PROGESTERONE 25 MG | Cancelled Pre Market |
| 02480247 | PMS-PROGESTERONE | PHARMASCIENCE INC | Capsule | PROGESTERONE 200 MG | Dormant |
| 00739952 | PMS-PROGESTERONE INJ 50MG/ML USP | PHARMASCIENCE INC | Liquid | PROGESTERONE 50 MG | Cancelled Post Market |
| 00270016 | PROGESTERONE 5% | VETOQUINOL N A INC | Solution | PROGESTERONE 50 MG | Cancelled Post Market |
| 01977652 | PROGESTERONE INJ 50MG/ML USP | CYTEX PHARMACEUTICALS INC | Liquid | PROGESTERONE 50 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 25568 | 2021-03-30 | New Drug Submission (NDS) | CHANGE IN PRODUCT OWNERSHIP |
| 18372 | 2016-08-16 | Supplement to a New Drug Submission (SNDS) | UPDATE TO THE PRODUCT MONOGRAPH IN RESPONSE TO AN ADVISEMENT LETTER DATED MAY 13, 2016 |
| 12173 | 2011-03-17 | New Drug Submission (NDS) | Manufacturer name change |
| 5221 | 1995-05-15 | New Drug Submission (NDS) |
International API supply for PROGESTERONE
5 valid EDQM Certificates of Suitability from 5 holders. 29 active FDA Drug Master Files.
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