Details for New Drug Application (NDA): 216579
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NDA 216579 describes SYMBICORT AEROSPHERE, which is a drug marketed by Astrazeneca and is included in one NDA. There are two patents protecting this drug. Additional details are available on the SYMBICORT AEROSPHERE profile page.
The generic ingredient in SYMBICORT AEROSPHERE 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 AEROSPHERE 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 216579
| Tradename: | SYMBICORT AEROSPHERE |
| Applicant: | Astrazeneca |
| Ingredient: | budesonide; formoterol fumarate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216579
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.16MG/INH;0.0048MG/INH | ||||
| Approval Date: | Apr 28, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 28, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
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