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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 020929


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NDA 020929 describes PULMICORT RESPULES, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PULMICORT RESPULES profile page.

The generic ingredient in PULMICORT RESPULES is budesonide. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 020929
Tradename:PULMICORT RESPULES
Applicant:Astrazeneca Pharms
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020929
Medical Subject Heading (MeSH) Categories for 020929
Suppliers and Packaging for NDA: 020929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929 NDA AstraZeneca Pharmaceuticals LP 0186-1988 0186-1988-04 6 POUCH in 1 CARTON (0186-1988-04) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929 NDA AstraZeneca Pharmaceuticals LP 0186-1989 0186-1989-04 6 POUCH in 1 CARTON (0186-1989-04) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
Paragraph IV (Patent) Challenges for 020929
Tradename Dosage Ingredient NDA Submissiondate
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2010-05-28
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2005-09-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Aug 8, 2000TE:ANRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Aug 8, 2000TE:ANRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength1MG/2ML
Approval Date:Aug 8, 2000TE:ANRLD:Yes

Expired US Patents for NDA 020929

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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