budesonide; formoterol fumarate dihydrate · Astrazeneca · NDA 021929
Symbicort
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 212212, Teva Pharms Usa Inc · 021929-001Approved 23 Apr 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021929 · 001 · RLD | aerosol, metered, inhalation | 0.08MG/INH;0.0045MG/INH | open |
| 021929 · 002 · RLD | aerosol, metered, inhalation | 0.16MG/INH;0.0045MG/INH | open |