Orange Book product · Generic (ANDA)
BUDESONIDE
BUDESONIDE
At a glance
Mar 30, 2009
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 30, 2009
17 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
0.25MG/2ML
Dosage form
SUSPENSION
Route
INHALATION
TE code
AN
Application
ANDA 078202
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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- 2006PULMICORT FLEXHALERBrand (NDA)
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- 2001ENTOCORT ECBrand (NDA)
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- 2000PULMICORT RESPULESBrand (NDA)
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- 1997PULMICORTBrand (NDA)
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- 1994RHINOCORTBrand (NDA)
NDA 020233 · ASTRAZENECA
- 2023BUDESONIDEGeneric (ANDA)
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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.
