Orange Book product · Generic (ANDA)
BUDESONIDE
BUDESONIDE
At a glance
Nov 20, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2015
10 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
0.032MG/SPRAY
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
ANDA 078949
Product number
002
Marketing status
OTC
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)
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- 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.
