Orange Book product · Generic (ANDA)
BUDESONIDE
BUDESONIDE
At a glance
Sep 28, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
3MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 209041
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUDESONIDE
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- 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
- 2000PULMICORT RESPULESBrand (NDA)
NDA 020929 · ASTRAZENECA
- 1997PULMICORTBrand (NDA)
NDA 020441 · ASTRAZENECA
- 1994RHINOCORTBrand (NDA)
NDA 020233 · ASTRAZENECA
- 2023BUDESONIDEGeneric (ANDA)
ANDA 216667 · EUGIA PHARMA
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.
