PULMICORT NEBUAMP 0.5 MG/ML DIN 01978926
Health Canada record
| Active ingredient(s) | BUDESONIDE 0.5 MG |
|---|---|
| Dosage form | Suspension |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03BA02 BUDESONIDE |
| Original market date | 31-Dec-1992 |
| Current status date | 15-Dec-2002 |
| 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 BUDESONIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02518058 | BREZTRI AEROSPHERE | ASTRAZENECA CANADA INC | Aerosol (Metered-Dose) | BUDESONIDE 160 MCG; GLYCOPYRRONIUM (GLYCOPYRROLATE) 7.2 MCG; FORMOTEROL FUMARATE DIHYDRATE 5 MCG | Marketed |
| 02455889 | CORTIMENT | FERRING INC | Tablet (Delayed- And Extended-Release) | BUDESONIDE 9 MG | Marketed |
| 02229293 | ENTOCORT | TILLOTTS PHARMA GMBH | Capsule (Sustained-Release) | BUDESONIDE 3 MG | Marketed |
| 02052431 | ENTOCORT ENEMA | TILLOTTS PHARMA GMBH | Enema; Tablet; Kit | BUDESONIDE 2.3 MG | Marketed |
| 02513854 | JORVEZA | AVIR PHARMA INC. | Tablet (Orally-Disintegrating) | BUDESONIDE 0.5 MG | Marketed |
| 02493675 | JORVEZA | AVIR PHARMA INC. | Tablet (Orally-Disintegrating) | BUDESONIDE 1 MG | Marketed |
| 02230648 | MYLAN-BUDESONIDE AQ | MYLAN PHARMACEUTICALS ULC | Spray (Metered-Dose) | BUDESONIDE 100 MCG | Marketed |
| 02241003 | MYLAN-BUDESONIDE AQ | MYLAN PHARMACEUTICALS ULC | Spray (Metered-Dose) | BUDESONIDE 64 MCG | Marketed |
| 02229099 | PULMICORT NEBUAMP 0.125 MG/ML | ASTRAZENECA CANADA INC | Suspension | BUDESONIDE 0.125 MG | Marketed |
| 01978918 | PULMICORT NEBUAMP 0.25 MG/ML | ASTRAZENECA CANADA INC | Suspension | BUDESONIDE 0.25 MG | Marketed |
| 00851752 | PULMICORT TURBUHALER | ASTRAZENECA CANADA INC | Powder (Metered-Dose) | BUDESONIDE 200 MCG | Marketed |
| 00851760 | PULMICORT TURBUHALER | ASTRAZENECA CANADA INC | Powder (Metered-Dose) | BUDESONIDE 400 MCG | Marketed |
| 00852074 | PULMICORT TURBUHALER | ASTRAZENECA CANADA INC | Powder (Metered-Dose) | BUDESONIDE 100 MCG | Marketed |
| 02231923 | RHINOCORT AQUA | KENVUE CANADA INC. | Spray (Metered-Dose) | BUDESONIDE 64 MCG | Marketed |
| 02245385 | SYMBICORT 100 TURBUHALER | ASTRAZENECA CANADA INC | Powder | BUDESONIDE 100 MCG; FORMOTEROL FUMARATE DIHYDRATE 6 MCG | Marketed |
| 02245386 | SYMBICORT 200 TURBUHALER | ASTRAZENECA CANADA INC | Powder | BUDESONIDE 200 MCG; FORMOTEROL FUMARATE DIHYDRATE 6 MCG | Marketed |
| 02248218 | SYMBICORT FORTE TURBUHALER | ASTRAZENECA CANADA INC | Powder | BUDESONIDE 400 MCG; FORMOTEROL FUMARATE DIHYDRATE 12 MCG | Approved |
| 02494272 | TARO-BUDESONIDE | TARO PHARMACEUTICALS INC | Suspension | BUDESONIDE 0.25 MG | Marketed |
| 02494264 | TARO-BUDESONIDE | TARO PHARMACEUTICALS INC | Suspension | BUDESONIDE 0.125 MG | Marketed |
| 02494280 | TARO-BUDESONIDE | TARO PHARMACEUTICALS INC | Suspension | BUDESONIDE 0.5 MG | Marketed |
| 02465949 | TEVA-BUDESONIDE | TEVA CANADA LIMITED | Suspension | BUDESONIDE 0.125 MG | Marketed |
| 02465957 | TEVA-BUDESONIDE | TEVA CANADA LIMITED | Suspension | BUDESONIDE 0.5 MG | Marketed |
| 02535416 | TEVA-BUDESONIDE | TEVA CANADA LIMITED | Suspension | BUDESONIDE 0.25 MG | Marketed |
| 02498057 | UCERIS | BAUSCH HEALTH, CANADA INC. | Foam | BUDESONIDE 2 MG | Marketed |
| 02483874 | BUDESONIDE | TILLOTTS PHARMA GMBH | Capsule (Sustained-Release) | BUDESONIDE 3 MG | Dormant |
| 01974432 | RHINOCORT AQUA 100MCG | ASTRA PHARMA INC. | Metered-Dose Aerosol | BUDESONIDE 100 MCG | Cancelled Post Market |
| 02035324 | RHINOCORT TURBUHALER 100 MCG/DOSE | ASTRAZENECA CANADA INC | Powder | BUDESONIDE 100 MCG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 1019 | 2000-01-28 | New Drug Submission (NDS) |
International API supply for BUDESONIDE
15 valid EDQM Certificates of Suitability from 14 holders. 28 active FDA Drug Master Files.
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