← FDA DRUG APPROVALS

FDA NDA · NDA021929

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Sponsor: ASTRAZENECA

APPLICATION
NDA021929
TYPE
NDA
ORIGINAL APPROVAL
2006-07-21
LATEST ACTION
2017-12-20
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

SYMBICORT · ReferencePrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION
SYMBICORT · ReferencePrescription
BUDESONIDE 0.08MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION

Approval history

2017-12-20Efficacy · Supplement 42 · standard — Label ↗AP
2017-09-11Efficacy · Supplement 41 · standard — Label ↗AP
2017-01-27Efficacy · Supplement 13 · unknown — Label ↗AP
2016-06-10Manufacturing (CMC) · Supplement 40 · standardAP
2015-04-14Manufacturing (CMC) · Supplement 38 · standardAP
2014-06-28Manufacturing (CMC) · Supplement 39 · standardAP
2014-04-04Manufacturing (CMC) · Supplement 37 · standardAP
2014-02-27Manufacturing (CMC) · Supplement 36 · standardAP
2014-01-15Manufacturing (CMC) · Supplement 35 · standardAP
2012-07-23REMS · Supplement 33 — Letter ↗AP
2012-05-08Manufacturing (CMC) · Supplement 30AP
2011-08-18REMS · Supplement 28 — Letter ↗AP
2011-02-16REMS · Supplement 19 — Letter ↗AP
2010-06-25Labeling · Supplement 21 · 901 order — Label ↗AP
2009-02-27Efficacy · Supplement 12 · standard — Review ↗AP
2008-07-16Labeling · Supplement 10 · standard — Label ↗AP
2007-10-31Labeling · Supplement 4 · standard — Label ↗AP
2007-10-26Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2006-07-21Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →