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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020441

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NDA 020441 describes PULMICORT, which is a drug marketed by Astrazeneca and Cheplapharm and is included in three NDAs. Additional details are available on the PULMICORT profile page.

The generic ingredient in PULMICORT is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 020441

Tradename:	PULMICORT
Applicant:	Astrazeneca
Ingredient:	budesonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 020441

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER, METERED;INHALATION			Strength	0.16MG/INH
Approval Date:	Jun 24, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER, METERED;INHALATION			Strength	0.32MG/INH
Approval Date:	Jun 24, 1997	TE:		RLD:	No

Expired US Patents for NDA 020441

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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