Details for New Drug Application (NDA): 216579

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.

Summary for 216579

Tradename:	SYMBICORT AEROSPHERE
Applicant:	Astrazeneca
Ingredient:	budesonide; formoterol fumarate
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216579

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.

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:		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:		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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