FDA NDA · NDA022206

RAPAFLO

Sponsor: ABBVIE

APPLICATION

NDA022206

TYPE

NDA

ORIGINAL APPROVAL

2008-10-08

LATEST ACTION

2020-12-15

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

RAPAFLO · ReferenceDiscontinued

SILODOSIN 4MG · CAPSULE · ORAL

RAPAFLO · ReferenceDiscontinued

SILODOSIN 8MG · CAPSULE · ORAL

2020-12-15Labeling · Supplement 16 · standard — Letter ↗AP

2015-12-21Manufacturing (CMC) · Supplement 10 · standardAP

2013-11-08Manufacturing (CMC) · Supplement 13 · standardAP

2013-07-12Labeling · Supplement 12 · standard — Letter ↗AP

2013-06-24Manufacturing (CMC) · Supplement 11 · standardAP

2012-12-14Labeling · Supplement 8 · unknown — Letter ↗AP

2010-03-04Labeling · Supplement 6 · unknown — Label ↗AP

2009-02-13Manufacturing (CMC) · Supplement 1 — Label ↗AP

2008-10-08Type 1 - New Molecular Entity · Original · standard — Review ↗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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