Orange Book product · Brand (NDA)
ENTOCORT EC
BUDESONIDE
At a glance
Oct 02, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 02, 2001
25 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
3MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021324
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
- 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.
