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Serving leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
US Department of Justice
Deloitte
Healthtrust
Moodys
QuintilesIMS
Harvard Business School
UBS
Express Scripts

Generated: October 23, 2017

DrugPatentWatch Database Preview

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 three 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 drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 021949

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.08MG/INH
Approval Date:Jul 12, 2006TE:RLD:Yes
Patent:► SubscribePatent 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:► SubscribePatent Expiration:May 8, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jan 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021949

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-001Jul 12, 2006► Subscribe► Subscribe
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-002Jul 12, 2006► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
Mallinckrodt
US Department of Justice
Cipla
Cerilliant
Covington
McKesson
Moodys
Medtronic

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