FDA Orange Book · active-ingredient family
Budesonide; formoterol fumarate dihydrate
Budesonide; formoterol fumarate dihydrate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYMBICORT · NDA 021929
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYMBICORTRLD×2 | ASTRAZENECA | NDA 021929 | AB | Jul 21, 2006 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE×2 | TEVA PHARMS USA INC | ANDA 212212 | AB | Apr 23, 2026 | |
| BREYNA×2 | MYLAN | ANDA 211699 | AB | Mar 15, 2022 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Budesonide; formoterol fumarate dihydrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
