Details for New Drug Application (NDA): 211699
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NDA 211699 describes BREYNA, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the BREYNA profile page.
The generic ingredient in BREYNA is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
The generic ingredient in BREYNA is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
Summary for 211699
| Tradename: | BREYNA |
| Applicant: | Mylan |
| Ingredient: | budesonide; formoterol fumarate dihydrate |
| Patents: | 0 |
Pharmacology for NDA: 211699
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 211699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7502 | 0378-7502-32 | 1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER |
| BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7503 | 0378-7503-32 | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.08MG/INH;0.0045MG/INH | ||||
| Approval Date: | Mar 15, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.16MG/INH;0.0045MG/INH | ||||
| Approval Date: | Mar 15, 2022 | TE: | AB | RLD: | No | ||||
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