| 0310-6616-01 |
0310-6616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20260427 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 7.2 ug/1 |
120 AEROSOL, METERED in 1 INHALER (0310-6616-01) |
| 0310-6616-39 |
0310-6616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20260427 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 7.2 ug/1 |
28 AEROSOL, METERED in 1 INHALER (0310-6616-39) |
| 0310-6616-95 |
0310-6616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20260427 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 7.2 ug/1 |
28 AEROSOL, METERED in 1 INHALER (0310-6616-95) |
| 0310-4616-12 |
0310-4616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20200723 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 9 ug/1 |
120 AEROSOL, METERED in 1 INHALER (0310-4616-12) |
| 0310-4616-28 |
0310-4616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20200723 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 9 ug/1 |
28 AEROSOL, METERED in 1 INHALER (0310-4616-28) |
| 0310-4616-39 |
0310-4616 |
HUMAN PRESCRIPTION DRUG |
BREZTRI |
budesonide, glycopyrrolate, and formoterol fumarate |
AEROSOL, METERED |
RESPIRATORY (INHALATION) |
20200723 |
N/A |
NDA |
NDA212122 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
160 ug/1; 4.8 ug/1; 9 ug/1 |
28 AEROSOL, METERED in 1 INHALER (0310-4616-39) |