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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021949

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NDA 021949 describes PULMICORT FLEXHALER, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from three suppliers. Additional details are available on the PULMICORT FLEXHALER profile page.

The generic ingredient in PULMICORT FLEXHALER 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 021949

Tradename:	PULMICORT FLEXHALER
Applicant:	Cheplapharm
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 021949

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021949

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 021949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	A-S Medication Solutions	50090-2239	50090-2239-0	1 INHALER in 1 CARTON (50090-2239-0) / 120 AEROSOL, POWDER in 1 INHALER
PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	A-S Medication Solutions	50090-6796	50090-6796-0	1 INHALER in 1 CARTON (50090-6796-0) / 120 AEROSOL, POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER, METERED;INHALATION			Strength	0.08MG/INH
Approval Date:	Jul 12, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER, METERED;INHALATION			Strength	0.16MG/INH
Approval Date:	Jul 12, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021949

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	7,143,764	⤷ Get Started Free
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	7,143,764	⤷ Get Started Free
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,287,540	⤷ Get Started Free
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	4,907,583	⤷ Get Started Free
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,027,714	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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