| 50090-4508-0 |
50090-4508 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20190904 |
N/A |
NDA |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (50090-4508-0) / 1 AEROSOL in 1 POUCH |
| 50090-4509-0 |
50090-4509 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20190904 |
N/A |
NDA |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (50090-4509-0) / 1 AEROSOL in 1 POUCH |
| 50090-4510-0 |
50090-4510 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20190904 |
N/A |
NDA |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (50090-4510-0) / 1 AEROSOL in 1 POUCH |
| 0186-0370-20 |
0186-0370 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20070529 |
N/A |
NDA |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER |
| 0186-0370-28 |
0186-0370 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20070906 |
N/A |
NDA |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER |
| 0186-0372-20 |
0186-0372 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20070529 |
N/A |
NDA |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0186-0372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER |
| 0186-0372-28 |
0186-0372 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20070906 |
N/A |
NDA |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0186-0372-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER |
| 0310-7370-20 |
0310-7370 |
HUMAN PRESCRIPTION DRUG |
Budesonide and Formoterol Fumarate Dihydrate |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20200103 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0310-7370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER |
| 0310-7372-20 |
0310-7372 |
HUMAN PRESCRIPTION DRUG |
Budesonide and Formoterol Fumarate Dihydrate |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20200103 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021929 |
AstraZeneca Pharmaceuticals LP |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER |
| 50090-6327-0 |
50090-6327 |
HUMAN PRESCRIPTION DRUG |
Budesonide and Formoterol Fumarate Dihydrate |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20230112 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCH |
| 50090-6382-0 |
50090-6382 |
HUMAN PRESCRIPTION DRUG |
Budesonide and Formoterol Fumarate Dihydrate |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20230227 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 CANISTER in 1 CARTON (50090-6382-0) / 120 AEROSOL in 1 CANISTER |
| 53002-2666-1 |
53002-2666 |
HUMAN PRESCRIPTION DRUG |
Budesonide and Formoterol Fumarate Dihydrate |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20210101 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021929 |
RPK Pharmaceuticals, Inc. |
BUDESONIDE; FORMOTEROL FUMARATE |
80 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (53002-2666-1) / 1 AEROSOL in 1 POUCH |
| 50090-1403-0 |
50090-1403 |
HUMAN PRESCRIPTION DRUG |
SYMBICORT |
Budesonide and Formoterol Fumarate Dihydrate |
AEROSOL |
RESPIRATORY (INHALATION) |
20141128 |
N/A |
NDA |
NDA021929 |
A-S Medication Solutions |
BUDESONIDE; FORMOTEROL FUMARATE |
160 ug/1; 4.5 ug/1 |
1 POUCH in 1 CARTON (50090-1403-0) / 1 AEROSOL in 1 POUCH |