FDA NDA · NDA022522

DALIRESP

roflumilast

Sponsor: ASTRAZENECA

APPLICATION

NDA022522

TYPE

NDA

ORIGINAL APPROVAL

2011-02-28

LATEST ACTION

2018-01-23

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

DALIRESP · ReferencePrescription

ROFLUMILAST 500MCG · TABLET · ORAL

DALIRESP · ReferencePrescription

ROFLUMILAST 250MCG · TABLET · ORAL

2018-01-23Efficacy · Supplement 9 · standard — Label ↗AP

2017-08-31Efficacy · Supplement 8 · standard — Label ↗AP

2016-02-12Manufacturing (CMC) · Supplement 7 · standardAP

2015-11-24Labeling · Supplement 6 · standard — Label ↗AP

2014-09-17Manufacturing (CMC) · Supplement 4 · standardAP

2013-08-23Labeling · Supplement 3 · standard — Label ↗AP

2012-12-18Manufacturing (CMC) · Supplement 2 · standardAP

2012-04-11Manufacturing (CMC) · Supplement 1 · standardAP

2011-02-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP

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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