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FDA NDA · NDA021551

HALFLYTELY

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APPLICATION
NDA021551
TYPE
NDA
ORIGINAL APPROVAL
2004-05-10
LATEST ACTION
2013-06-03
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION, TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

HALFLYTELY · ReferenceDiscontinued
BISACODYL 5MG,N/A, POLYETHYLENE GLYCOL 3350 N/A,210GM, POTASSIUM CHLORIDE N/A,0.74GM, SODIUM BICARBONATE N/A,2.86GM, SODIUM CHLORIDE N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION, TABLET, DELAYED RELEASE · ORAL
HALFLYTELYDiscontinued
BISACODYL 5MG,N/A, POLYETHYLENE GLYCOL 3350 N/A,210GM, POTASSIUM CHLORIDE N/A,0.74GM, SODIUM BICARBONATE N/A,2.86GM, SODIUM CHLORIDE N/A,5.6GM · FOR SOLUTION, TABLET, DELAYED RELEASE · ORAL

Approval history

2013-06-03Manufacturing (CMC) · Supplement 18 · standardAP
2011-07-06REMS · Supplement 16 — Letter ↗AP
2010-07-16Efficacy · Supplement 13 · standard — Letter ↗AP
2008-01-18Manufacturing (CMC) · Supplement 8AP
2007-09-24Efficacy · Supplement 6 · unknown — Label ↗AP
2006-05-18Labeling · Supplement 5 · standard — Label ↗AP
2005-02-23Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2004-05-10Type 3 - New Dosage Form · 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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