FDA NDA · NDA020966

SPORANOX

Sponsor: JANSSEN PHARMS

APPLICATION

NDA020966

TYPE

NDA

ORIGINAL APPROVAL

1999-03-30

LATEST ACTION

2009-04-23

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

SPORANOXDiscontinued

ITRACONAZOLE 10MG/ML · INJECTABLE · INJECTION

2009-04-23Labeling · Supplement 22 · standard — Letter ↗AP

2009-03-05Labeling · Supplement 17 · standard — Letter ↗AP

2009-03-05Labeling · Supplement 18 · standard — Label ↗AP

2009-03-05Labeling · Supplement 20 · standard — Letter ↗AP

2004-07-14Labeling · Supplement 11 · standard — Label ↗AP

2002-10-10Manufacturing (CMC) · Supplement 10 · standardAP

2002-09-16Manufacturing (CMC) · Supplement 9 · standardAP

2002-08-02Manufacturing (CMC) · Supplement 7 · standardAP

2002-08-02Manufacturing (CMC) · Supplement 8 · standardAP

2002-07-17Labeling · Supplement 6 · standard — Letter ↗AP

2002-02-28Labeling · Supplement 5 · standard — Letter ↗AP

2001-05-09Labeling · Supplement 3 · standard — Review ↗AP

2001-05-09Labeling · Supplement 1 · standard — Label ↗AP

2001-05-09Efficacy · Supplement 4 · standard — Review ↗AP

1999-10-25Manufacturing (CMC) · Supplement 2 · standardAP

1999-03-30Type 3 - New Dosage Form · 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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