Suppliers and packages for generic ingredient: budesonide; formoterol fumarate dihydrate
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budesonide; formoterol fumarate dihydrate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan | BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7502-32 | 1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER | 2023-07-31 |
| Mylan | BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7503-32 | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER | 2023-07-31 |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-0370-20 | 1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER | 2007-05-29 |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-0370-28 | 1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER | 2007-05-29 |
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