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FDA NDA · NDA021097

VISICOL

Sponsor: SALIX PHARMS

APPLICATION
NDA021097
TYPE
NDA
ORIGINAL APPROVAL
2000-09-21
LATEST ACTION
2013-03-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VISICOLDiscontinued
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.398GM, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.102GM · TABLET · ORAL

Approval history

2013-03-07Labeling · Supplement 16 · standard — Letter ↗AP
2011-12-09REMS · Supplement 15 — Letter ↗AP
2009-10-13Labeling · Supplement 14 · standard — Review ↗AP
2009-03-25Labeling · Supplement 13 · 901 required — Label ↗AP
2006-03-31Labeling · Supplement 10 · standard — Letter ↗AP
2005-02-10Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2005-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2002-09-04Manufacturing (CMC) · Supplement 6 · standardAP
2002-03-12Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2001-09-26Manufacturing (CMC) · Supplement 4 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 2 · standardAP
2001-03-30Manufacturing (CMC) · Supplement 3 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 1 · standardAP
2000-09-21Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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