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Generated: December 10, 2018

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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. There are four patents protecting this drug. Additional details are available on the PULMICORT FLEXHALER profile page.

The generic ingredient in PULMICORT FLEXHALER is budesonide. There are twenty-one drug master file entries for this compound. Thirty-nine 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:4
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 0186-0916 0186-0916-65 1 INHALER in 1 CARTON (0186-0916-65) > 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
Patent:➤ Sign UpPatent Expiration:Jan 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL CORTICOSTEROID THERAPY FOR ASTHMA
Patent:➤ Sign UpPatent Expiration:May 8, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 9, 2018Product Flag?YSubstance Flag?Delist Request?

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 ➤ Sign Up ➤ Sign Up
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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