APPLICATION
ANDA079232
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-25
LATEST ACTION
2015-12-03
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
LAX-LYTE WITH FLAVOR PACKSDiscontinued
POLYETHYLENE GLYCOL 3350 420GM/BOT, POTASSIUM CHLORIDE 1.48GM/BOT, SODIUM BICARBONATE 5.72GM/BOT, SODIUM CHLORIDE 11.2GM/BOT · FOR SOLUTION · ORAL
Approval history
2015-12-03Labeling · Supplement 2 · standardAP
2010-02-25OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.