← FDA DRUG APPROVALS

FDA NDA · NDA020929

PULMICORT RESPULES

budesonide

Sponsor: ASTRAZENECA

APPLICATION
NDA020929
TYPE
NDA
ORIGINAL APPROVAL
2000-08-08
LATEST ACTION
2019-09-06
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

PULMICORT RESPULES · ReferencePrescription
BUDESONIDE 1MG/2ML · SUSPENSION · INHALATION
PULMICORT RESPULES · ReferencePrescription
BUDESONIDE 0.25MG/2ML · SUSPENSION · INHALATION
PULMICORT RESPULES · ReferencePrescription
BUDESONIDE 0.5MG/2ML · SUSPENSION · INHALATION

Approval history

2019-09-06Labeling · Supplement 52 · standard — Letter ↗AP
2015-08-18Manufacturing (CMC) · Supplement 51 · priorityAP
2013-05-15Manufacturing (CMC) · Supplement 49 · priorityAP
2013-04-10Manufacturing (CMC) · Supplement 50 · priorityAP
2010-07-02Labeling · Supplement 44 · standard — Label ↗AP
2009-10-05Labeling · Supplement 43 · standard — Letter ↗AP
2007-06-18Labeling · Supplement 32 · standard — Letter ↗AP
2007-06-15Manufacturing (CMC) · Supplement 34AP
2006-11-20Labeling · Supplement 29 · standardAP
2006-07-21Manufacturing (CMC) · Supplement 2 · priority — Letter ↗AP
2005-06-30Efficacy · Supplement 22 · unknown — Letter ↗AP
2003-09-26Labeling · Supplement 15 · standard — Review ↗AP
2003-02-26Efficacy · Supplement 13 · standard — Label ↗AP
2003-01-10Labeling · Supplement 12 · standard — Letter ↗AP
2002-07-25Manufacturing (CMC) · Supplement 11 · priorityAP
2001-09-24Manufacturing (CMC) · Supplement 9 · priorityAP
2001-07-16Manufacturing (CMC) · Supplement 3 · priorityAP
2001-06-18Manufacturing (CMC) · Supplement 5 · priorityAP
2001-05-16Manufacturing (CMC) · Supplement 7 · priorityAP
2001-05-16Manufacturing (CMC) · Supplement 8 · priorityAP
2001-05-16Manufacturing (CMC) · Supplement 6 · priorityAP
2001-04-25Manufacturing (CMC) · Supplement 4 · priorityAP
2001-02-09Manufacturing (CMC) · Supplement 1 · priorityAP
2000-08-08Type 3 - New Dosage Form · Original · priority — Pediatric Written Request ↗AP
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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