Orange Book product · Brand (NDA)
PULMICORT RESPULES
BUDESONIDE
At a glance
Aug 08, 2000
Approved
Brand (NDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 08, 2000
26 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
0.25MG/2ML
Dosage form
SUSPENSION
Route
INHALATION
TE code
AN
Application
NDA 020929
Product number
001
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
- 2006PULMICORT FLEXHALERBrand (NDA)
NDA 021949 · CHEPLAPHARM
- 2001ENTOCORT ECBrand (NDA)
NDA 021324 · PADAGIS US
- 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.
