Details for New Drug Application (NDA): 212122
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The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.
Summary for 212122
Tradename: | BREZTRI AEROSPHERE |
Applicant: | Astrazeneca Ab |
Ingredient: | budesonide; formoterol fumarate; glycopyrrolate |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212122
Generic Entry Date for 212122*:
Constraining patent/regulatory exclusivity:
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: 212122
Suppliers and Packaging for NDA: 212122
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4616 | 0310-4616-12 | 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) |
BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4616 | 0310-4616-28 | 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.16MG/INH;0.0048MG/INH;0.009MG/INH | ||||
Approval Date: | Jul 23, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 28, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 5, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 5, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? |
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