Pulmicort

NDA 20441, held by Astrazeneca. Budesonide.

As of Nov 13, 2026, NDA 20441 (Pulmicort), held by Astrazeneca, was first approved by FDA on Jun 24, 1997, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 24, 1997
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 8, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jun 24, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Pulmicort0.16MG/INH · powder, metered;inhalation	Budesonide	Discontinued
Pulmicort0.32MG/INH · powder, metered;inhalation	Budesonide	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 20, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 17, 2003	Supplement 17Labeling · Standard review	Approved	Review Label Letter
Oct 24, 2003	Supplement 16Labeling · Standard review	Approved	Review Letter Label
Sep 26, 2003	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Dec 31, 2001	Supplement 12Labeling · Standard review	Approved	Review Letter
Oct 15, 2001	Supplement 10Manufacturing · Standard review	Approved	Review
Jul 3, 2001	Supplement 13Manufacturing · Standard review	Approved	Review
Jun 18, 2001	Supplement 11Manufacturing · Standard review	Approved	Review
May 18, 2001	Supplement 14Manufacturing · Standard review	Approved	Review
Dec 9, 2000	Supplement 9Manufacturing · Standard review	Approved	Review
Feb 2, 2000	Supplement 7Manufacturing · Standard review	Approved	Review
May 21, 1999	Supplement 5Manufacturing · Standard review	Approved	Review
Apr 12, 1999	Supplement 3Manufacturing · Standard review	Approved	Review
Oct 8, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Feb 11, 1998	Supplement 1Manufacturing · Standard review	Approved	Review
Jun 24, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20441
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters