BREZTRI is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide; Glycopyrrolate; Formoterol.
Product ID | 0310-4616_13ad4a6e-cfa4-4c95-a243-a4ebad234ed4 |
NDC | 0310-4616 |
Product Type | Human Prescription Drug |
Proprietary Name | BREZTRI |
Generic Name | Budesonide, Glycopyrrolate, And Formoterol Fumarate |
Dosage Form | Aerosol, Metered |
Route of Administration | RESPIRATORY (INHALATION) |
Marketing Start Date | 2020-07-23 |
Marketing Category | NDA / NDA |
Application Number | NDA212122 |
Labeler Name | AstraZeneca Pharmaceuticals LP |
Substance Name | BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL |
Active Ingredient Strength | 160 ug/1; ug/1; ug/1 |
Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2020-07-23 |
NDC Exclude Flag | N |
Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BREZTRI 87805396 not registered Live/Pending |
AstraZeneca AB 2018-02-21 |