Details for New Drug Application (NDA): 021929
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NDA 021929 describes SYMBICORT, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from three suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYMBICORT profile page.
The generic ingredient in SYMBICORT is budesonide; formoterol fumarate. There are twenty-two drug master file entries for this compound. Additional details are available on the budesonide; formoterol fumarate profile page.
The generic ingredient in SYMBICORT is budesonide; formoterol fumarate. There are twenty-two drug master file entries for this compound. Additional details are available on the budesonide; formoterol fumarate profile page.
Summary for 021929
| Tradename: | SYMBICORT |
| Applicant: | Astrazeneca |
| Ingredient: | budesonide; formoterol fumarate dihydrate |
| Patents: | 5 |
Pharmacology for NDA: 021929
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 021929
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-0370 | 0186-0370-20 | 1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER |
| SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-0370 | 0186-0370-28 | 1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL 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: | Jul 21, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 10, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 16, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021929
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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