Orange Book product · Generic (ANDA)
BUDESONIDE
BUDESONIDE
At a glance
Nov 16, 2017
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
0.25MG/2ML
Dosage form
SUSPENSION
Route
INHALATION
TE code
AN
Application
ANDA 205710
Product number
001
Marketing status
RX
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)
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- 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.
