Details for New Drug Application (NDA): 214070
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NDA 214070 describes AIRSUPRA, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the AIRSUPRA profile page.
The generic ingredient in AIRSUPRA is albuterol sulfate; budesonide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albuterol sulfate; budesonide profile page.
The generic ingredient in AIRSUPRA is albuterol sulfate; budesonide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albuterol sulfate; budesonide profile page.
Summary for 214070
| Tradename: | AIRSUPRA |
| Applicant: | Astrazeneca |
| Ingredient: | albuterol sulfate; budesonide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214070
Generic Entry Date for 214070*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
AEROSOL, METERED;INHALATION |
*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.
Pharmacology for NDA: 214070
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 214070
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9080 | 0310-9080-12 | 1 INHALER in 1 CARTON (0310-9080-12) / 120 AEROSOL, METERED in 1 INHALER |
| AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9080 | 0310-9080-28 | 1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH;0.08MG/INH | ||||
| Approval Date: | Jan 10, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 10, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 9,415,009 | Patent Expiration: | May 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | AS-NEEDED TREATMENT OR PREVENTION OF BRONCHOCONSTRICTION AND REDUCTION OF THE RISK OF EXACERBATIONS IN PATIENTS WITH ASTHMA 18 YEARS OF AGE AND OLDER | ||||||||
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