Drug
Who makes budesonide and formoterol fumarate dihydrate?
4 companies list budesonide and formoterol fumarate dihydrate as a human prescription drug, including under the names SYMBICORT. Forms: aerosol; aerosol, metered. Routes: respiratory (inhalation).
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing budesonide and formoterol fumarate dihydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | aerosol | NDA, NDA AUTHORIZED GENERICNDA021929 | 6 | 3 |
| AstraZeneca PLCUnited States | aerosol | NDA, NDA AUTHORIZED GENERICNDA021929 | 4 | 15 |
| Sportpharm LLC | aerosol | NDA, NDA AUTHORIZED GENERICNDA021929 | 3 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | aerosol, metered | ANDAANDA212212 | 2 | 6 |
Enquiry
Common questions
- Who makes budesonide and formoterol fumarate dihydrate?
- 4 companies list budesonide and formoterol fumarate dihydrate as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., AstraZeneca PLC, Sportpharm LLC, Teva Pharmaceutical Industries Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic SYMBICORT?
- 1 company lists budesonide and formoterol fumarate dihydrate under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.