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DALIRESP (nda022522)- (250MCG,500MCG)

ROFLUMILAST ASTRAZENECA
250MCG,500MCG
Yes No
2024-Mar-08 2016-Feb-28
None None
None No
DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
11 0 7
Total Other Developers 7
Drugs with Suitability No
250MCG ** ** Up - 4
500MCG ** ** Up - 7
NDA Sales Available Total Generic Sales Available
Yes 7
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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