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SYMBICORT (nda021929)- (0.08MG/INH;0.0045MG/INH,0.16MG/INH;0.0045MG/INH)

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE ASTRAZENECA
0.08MG/INH;0.0045MG/INH,0.16MG/INH;0.0045MG/INH
Yes No
2029-Oct-07 Expired
None None
None No
SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
1 0 1
Total Other Developers 10
Drugs with Suitability No
0.08MG/INH;0.0045MG/INH ** ** Up 1 -
0.16MG/INH;0.0045MG/INH ** ** Up - 1
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ***** ******* **** ******** *.*. *********** ***** ******** ******, **********, ********** (**) *****-****, ****** ****** (***) ***

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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