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Last Updated: December 12, 2019

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Details for New Drug Application (NDA): 021949

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NDA 021949 describes PULMICORT FLEXHALER, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from two 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. Thirty-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 021949
Tradename:PULMICORT FLEXHALER
Applicant:Astrazeneca
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021949
Medical Subject Heading (MeSH) Categories for 021949
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 AstraZeneca Pharmaceuticals LP 0186-0916 0186-0916-12 1 INHALER in 1 CARTON (0186-0916-12) > 120 AEROSOL, POWDER in 1 INHALER
PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949 NDA AstraZeneca Pharmaceuticals LP 0186-0917 0186-0917-06 1 INHALER in 1 CARTON (0186-0917-06) > 60 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
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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