FDA NDA · NDA020316

OXILAN-350

Sponsor: GUERBET

APPLICATION

NDA020316

TYPE

NDA

ORIGINAL APPROVAL

1995-12-21

LATEST ACTION

2017-04-05

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

OXILAN-350Discontinued

IOXILAN 73% · INJECTABLE · INJECTION

OXILAN-300Discontinued

IOXILAN 62% · INJECTABLE · INJECTION

2017-04-05Labeling · Supplement 29 · standard — Label ↗AP

2015-07-06Labeling · Supplement 28 · standard — Label ↗AP

2006-11-12Manufacturing (CMC) · Supplement 21 — Letter ↗AP

2003-01-06Labeling · Supplement 16 · standard — Letter ↗AP

2002-12-30Manufacturing (CMC) · Supplement 11 · standardAP

2002-08-12Manufacturing (CMC) · Supplement 14 · standardAP

2002-04-17Manufacturing (CMC) · Supplement 13 · standardAP

2001-12-18Manufacturing (CMC) · Supplement 12 · standardAP

2000-10-24Manufacturing (CMC) · Supplement 9 · standardAP

1999-01-04Manufacturing (CMC) · Supplement 8 · standardAP

1997-10-15Manufacturing (CMC) · Supplement 6 · standardAP

1997-05-22Manufacturing (CMC) · Supplement 7 · standardAP

1997-03-17Manufacturing (CMC) · Supplement 5 · standardAP

1995-12-21Type 1 - New Molecular Entity · Original · standardAP

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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