Advair Hfa Fda Approval
Advair hfa is a combination product containing a corticosteroid and a long acting beta 2 adrenergic agonist laba indicated for the twice daily treatment of asthma in patients aged 12 years and.
Advair hfa fda approval. Drug name active ingredients strength dosage form route marketing status te code rld rs. Advair hfa fluticasone propionate and salmeterol xinafoate inhalation aerosol company. Food and drug administration today approved the first generic of advair diskus fluticasone propionate and salmeterol inhalation powder for the twice daily treatment of asthma in patients.
1 888 info fda 1 888 463 6332 contact fda. April 22 2004 the fda has approved the first dual action asthma drug for use in young children. 10903 new hampshire avenue silver spring md 20993 ph.
Approval letter s pdf approvable letter pdf part 1 pdf part 2 pdf proprietary name review s pdf summary review pdf printed labeling pdf. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent fda hopes to avoid possible significant variations among generic drugs and their brand name counterpart. A drug company seeking approval to market a generic equivalent must refer to the reference listed drug in its abbreviated new drug application anda.
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