Orange Book product · Brand (NDA)
PULMICORT FLEXHALER
BUDESONIDE
At a glance
Jul 12, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 12, 2006
20 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
0.16MG/INH
Dosage form
POWDER, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 021949
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024EOHILIABrand (NDA)
NDA 213976 · TAKEDA PHARMS USA
- 2021TARPEYOBrand (NDA)
NDA 215935 · CALLIDITAS
- 2019ORTIKOSBrand (NDA)
NDA 211929 · SUN PHARM INDS INC
- 2015RHINOCORT ALLERGYBrand (NDA)
NDA 020746 · KENVUE BRANDS
- 2014UCERISBrand (NDA)
NDA 205613 · SALIX
- 2013UCERISBrand (NDA)
NDA 203634 · SALIX
- 2001ENTOCORT ECBrand (NDA)
NDA 021324 · PADAGIS US
- 2000PULMICORT RESPULESBrand (NDA)
NDA 020929 · ASTRAZENECA
- 1997PULMICORTBrand (NDA)
NDA 020441 · ASTRAZENECA
- 1994RHINOCORTBrand (NDA)
NDA 020233 · ASTRAZENECA
- 2023BUDESONIDEGeneric (ANDA)
ANDA 216667 · EUGIA PHARMA
- 2023BUDESONIDEGeneric (ANDA)
ANDA 215328 · PADAGIS ISRAEL
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.
