Details for New Drug Application (NDA): 212212
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NDA 212212 describes BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, which is a drug marketed by Teva Pharms Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE profile page.
The generic ingredient in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
The generic ingredient in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
Summary for 212212
| Tradename: | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | budesonide; formoterol fumarate dihydrate |
| Patents: | 0 |
Pharmacology for NDA: 212212
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 212212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 212212 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3080 | 0480-3080-31 | 1 POUCH in 1 CARTON (0480-3080-31) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 212212 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3081 | 0480-3081-31 | 1 POUCH in 1 CARTON (0480-3081-31) / 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: | Apr 23, 2026 | 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: | Apr 23, 2026 | TE: | AB | RLD: | No | ||||
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