← FDA DRUG APPROVALS

FDA NDA · NDA020441

PULMICORT

Sponsor: ASTRAZENECA

APPLICATION
NDA020441
TYPE
NDA
ORIGINAL APPROVAL
1997-06-24
LATEST ACTION
2007-08-20
ROUTE
INHALATION
DOSAGE FORM
POWDER, METERED
MARKETING STATUS
Discontinued

Products

PULMICORTDiscontinued
BUDESONIDE 0.16MG/INH · POWDER, METERED · INHALATION
PULMICORTDiscontinued
BUDESONIDE 0.32MG/INH · POWDER, METERED · INHALATION

Approval history

2007-08-20Labeling · Supplement 20 · standard — Label ↗AP
2003-12-17Labeling · Supplement 17 · standard — Review ↗AP
2003-10-24Labeling · Supplement 16 · standard — Review ↗AP
2003-09-26Labeling · Supplement 18 · standard — Review ↗AP
2001-12-31Labeling · Supplement 12 · standard — Review ↗AP
2001-10-15Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2001-07-03Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP
2001-06-18Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
2001-05-18Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
2000-12-09Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2000-02-02Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1999-05-21Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1999-04-12Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1998-10-08Efficacy · Supplement 2 · standard — Review ↗AP
1998-02-11Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1997-06-24Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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