SYNOTIC DIN 02237340
Health Canada record
| Active ingredient(s) | FLUOCINOLONE ACETONIDE 0.01 %; DIMETHYL SULFOXIDE 60 % |
|---|---|
| Dosage form | Solution |
| Route | Otic |
| Schedule | PRESCRIPTION |
| Class | Veterinary |
| ATC | |
| Original market date | 29-Jan-1999 |
| Current status date | 20-Jul-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Zoetis Canada Inc — licence 102076, currently licensed, last inspection rating C (2023-10-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUOCINOLONE ACETONIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00873292 | DERMA SMOOTHE/FS LIQ 0.01% | HILL DERMACEUTICALS INC | Emulsion | FLUOCINOLONE ACETONIDE 0.01 % | Marketed |
| 02300559 | DERMOTIC OIL EAR DROPS | HILL DERMACEUTICALS INC | Solution | FLUOCINOLONE ACETONIDE 0.01 % | Marketed |
| 02242738 | CAPEX | GALDERMA CANADA INC. | Shampoo | FLUOCINOLONE ACETONIDE 0.01 % | Cancelled Post Market |
| 00716812 | FLUODERM ONT 0.025% | TARO PHARMACEUTICALS INC | Ointment | FLUOCINOLONE ACETONIDE 0.25 MG | Cancelled Post Market |
| 02483157 | ILUVIEN | KNIGHT THERAPEUTICS INC. | Implant | FLUOCINOLONE ACETONIDE 0.19 MG | Cancelled Pre Market |
| 02306980 | RETISERT | BAUSCH & LOMB INC | Implant | FLUOCINOLONE ACETONIDE 0.59 MG | Dormant |
| 02162504 | SYNALAR | BAUSCH HEALTH, CANADA INC. | Solution | FLUOCINOLONE ACETONIDE 0.01 % | Cancelled Post Market |
| 02162512 | SYNALAR | BAUSCH HEALTH, CANADA INC. | Ointment | FLUOCINOLONE ACETONIDE 0.025 % | Dormant |
| 00189499 | SYNALAR BI-OTIC SOLUTION | MEDICIS CANADA LTD. | Solution | FLUOCINOLONE ACETONIDE 0.25 MG; NEOMYCIN (NEOMYCIN SULFATE) 3.5 MG; POLYMYXIN B SULFATE 10000 UNIT | Cancelled Post Market |
| 00030422 | SYNALAR CREAM 0.025% | MEDICIS CANADA LTD. | Cream | FLUOCINOLONE ACETONIDE 0.025 % | Cancelled Post Market |
| 00030414 | SYNALAR CREAM MILD 0.01% | MEDICIS CANADA LTD. | Cream | FLUOCINOLONE ACETONIDE 0.01 % | Cancelled Post Market |
| 00030392 | SYNALAR OINTMENT MILD 0.01% | MEDICIS CANADA LTD. | Ointment | FLUOCINOLONE ACETONIDE 0.01 % | Cancelled Post Market |
| 00424927 | SYNAMOL MILD 0.01% CREAM | MEDICIS CANADA LTD. | Cream | FLUOCINOLONE ACETONIDE 0.01 % | Cancelled Post Market |
| 00424935 | SYNAMOL REGULAR 0.025% CREAM | MEDICIS CANADA LTD. | Cream | FLUOCINOLONE ACETONIDE 0.025 % | Cancelled Post Market |
| 00507229 | SYNOTIC OTIC SOLUTION | SYNTEX ANIMAL HEALTH, DIVISION OF SYNTEX INC. | Solution | FLUOCINOLONE ACETONIDE 0.01 %; DIMETHYL SULFOXIDE 60 % | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 15300 | 2014-02-24 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER (DIN) HOLDER |
| 12936 | 2012-01-19 | New Drug Submission (NDS) | Change in Ownership |
| 10228 | 2009-05-29 | Supplement to a New Drug Submission (SNDS) | Alternate source of active ingredient |
| 8472 | 2006-12-19 | New Drug Submission (NDS) | |
| 6930 | 1998-02-18 | New Drug Submission (NDS) |
International API supply for FLUOCINOLONE ACETONIDE
2 valid EDQM Certificates of Suitability from 2 holders. 4 active FDA Drug Master Files.
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