OXEZE TURBUHALER DIN 02237225
Health Canada record
| Active ingredient(s) | FORMOTEROL FUMARATE DIHYDRATE 6 MCG |
|---|---|
| Dosage form | Powder |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03AC13 FORMOTEROL |
| Original market date | 12-Mar-1998 |
| Current status date | 01-Jun-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
AstraZeneca Canada Inc. — licence 100421, currently licensed, last inspection rating C (2023-06-12).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FORMOTEROL FUMARATE DIHYDRATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02237224 | OXEZE TURBUHALER | ASTRAZENECA CANADA INC | Powder | FORMOTEROL FUMARATE DIHYDRATE 12 MCG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18145 | 2016-06-01 | Supplement to a New Drug Submission (SNDS) | TO REPLACE THE TURBOHALER M2 WITH THE TURBOHALER M3 DEVICE |
| 1178 | 2000-02-08 | New Drug Submission (NDS) | |
| 2925 | 1998-02-18 | New Drug Submission (NDS) |
International API supply for FORMOTEROL FUMARATE DIHYDRATE
6 valid EDQM Certificates of Suitability from 6 holders. 6 active FDA Drug Master Files.
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