APPLICATION
ANDA090600
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-06
LATEST ACTION
2012-06-07
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
GLYCOLAXDiscontinued
POLYETHYLENE GLYCOL 3350 17GM/PACKET · FOR SOLUTION · ORAL
GLYCOLAXDiscontinued
POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL · FOR SOLUTION · ORAL
Approval history
2012-06-07Labeling · Supplement 7AP
2011-10-21Manufacturing (CMC) · Supplement 4AP
2010-03-08Labeling · Supplement 1AP
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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