FDA NDA · NDA020892

VALSTAR

valrubicin

Sponsor: ENDO OPERATIONS

APPLICATION

NDA020892

TYPE

NDA

ORIGINAL APPROVAL

1998-09-25

LATEST ACTION

2016-04-07

ROUTE

INTRAVESICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

VALSTAR PRESERVATIVE FREE · ReferencePrescription

VALRUBICIN 40MG/ML · SOLUTION · INTRAVESICAL

2016-04-07Labeling · Supplement 19 · standard — Letter ↗AP

2014-01-17Manufacturing (CMC) · Supplement 18 · priorityAP

2013-11-12Manufacturing (CMC) · Supplement 17 · priorityAP

2013-08-02Efficacy · Supplement 16 · standard — Letter ↗AP

2012-12-20Manufacturing (CMC) · Supplement 15 · priorityAP

2011-11-02Labeling · Supplement 13 · unknown — Letter ↗AP

2001-04-24Manufacturing (CMC) · Supplement 2 · priorityAP

1999-08-05Manufacturing (CMC) · Supplement 1 · priorityAP

1998-09-25Type 1 - New Molecular Entity · Original · priority — 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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