Product NDC: | 0186-0372 |
Proprietary Name: | SYMBICORT |
Non Proprietary Name: | Budesonide and Formoterol Fumarate Dihydrate |
Active Ingredient(s): | 80; 4.5 ug/1; ug/1 & nbsp; Budesonide and Formoterol Fumarate Dihydrate |
Administration Route(s): | RESPIRATORY (INHALATION) |
Dosage Form(s): | AEROSOL |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0186-0372 |
Labeler Name: | AstraZeneca LP |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021929 |
Marketing Category: | NDA |
Start Marketing Date: | 20070529 |
Package NDC: | 0186-0372-28 |
Package Description: | 1 POUCH in 1 CARTON (0186-0372-28) > 1 CANISTER in 1 POUCH > 60 AEROSOL in 1 CANISTER |
NDC Code | 0186-0372-28 |
Proprietary Name | SYMBICORT |
Package Description | 1 POUCH in 1 CARTON (0186-0372-28) > 1 CANISTER in 1 POUCH > 60 AEROSOL in 1 CANISTER |
Product NDC | 0186-0372 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Budesonide and Formoterol Fumarate Dihydrate |
Dosage Form Name | AEROSOL |
Route Name | RESPIRATORY (INHALATION) |
Start Marketing Date | 20070529 |
Marketing Category Name | NDA |
Labeler Name | AstraZeneca LP |
Substance Name | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE |
Strength Number | 80; 4.5 |
Strength Unit | ug/1; ug/1 |
Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |