OSURNIA DIN 02438534
Health Canada record
| Active ingredient(s) | BETAMETHASONE ACETATE 1 MG; FLORFENICOL 10 MG; TERBINAFINE 10 MG |
|---|---|
| Dosage form | Gel |
| Route | Otic |
| Schedule | PRESCRIPTION |
| Class | Veterinary |
| ATC | |
| Original market date | 02-Nov-2015 |
| Current status date | 06-Oct-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Dechra Veterinary Products Inc. — licence 102149, currently licensed, last inspection rating C (2025-05-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BETAMETHASONE ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00028096 | CELESTONE SOLUSPAN | ORGANON CANADA INC. | Suspension | BETAMETHASONE ACETATE 3 MG; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 3 MG | Marketed |
| 02556529 | DUOTIC | DECHRA LTD | Gel | BETAMETHASONE ACETATE 1 MG; TERBINAFINE 10 MG | Marketed |
| 02237835 | BETAJECT | SANDOZ CANADA INCORPORATED | Suspension | BETAMETHASONE ACETATE 3 MG; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 3 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 24232 | 2020-09-16 | New Drug Submission (NDS) | CHANGE IN PRODUCT OWNERSHIP |
| 23338 | 2020-03-16 | Supplement to a New Drug Submission (SNDS) | Addition of drug manufacturing and testing site |
| 21962 | 2019-03-12 | Supplement to a New Drug Submission (SNDS) | ADDITION OF DRUG SUBSTANCE MANUFACTURING AND TESTING SITE |
| 16723 | 2015-03-26 | New Drug Submission (NDS) |
International API supply for BETAMETHASONE ACETATE
4 active FDA Drug Master Files.
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