Last Updated: November 8, 2026

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 is one drug master file entry for this compound. Forty 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 ActionCorticosteroid 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:RXDosage:POWDER, METERED;INHALATIONStrength0.08MG/INH
Approval Date:Jul 12, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.16MG/INH
Approval Date:Jul 12, 2006TE:RLD:Yes

Expired US Patents for NDA 021949

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 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 6,287,540 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 6,142,145 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 4,907,583 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 6,287,540 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 7,143,764 ⤷  Start Trial
Cheplapharm PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 6,027,714 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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