0378-7503Level 3
BREYNA (Budesonide and Formoterol Fumarate)
**Product type:** Human Prescription Drug
**Active ingredient:** BUDESONIDE; FORMOTEROL FUMARATE
**Strength:** 160; 4.5 ug/1; ug/1
**Dosage form:** Aerosol, Metered
**Route:** Respiratory (Inhalation)
**Labeler:** Mylan Pharmaceuticals Inc.
**Marketing category:** ANDA (ANDA211699)
**Pharmacologic class:** Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
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