APPLICATION
ANDA090685
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-06
LATEST ACTION
2022-06-16
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Over-the-counter
Products
POLYETHYLENE GLYCOL 3350Over-the-counter
POLYETHYLENE GLYCOL 3350 17GM/PACKET · FOR SOLUTION · ORAL
POLYETHYLENE GLYCOL 3350Over-the-counter
POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL · FOR SOLUTION · ORAL
Approval history
2022-06-16Manufacturing (CMC) · Supplement 14 · unknownAP
2021-10-13Labeling · Supplement 13 · standardAP
2021-10-13Labeling · Supplement 11 · standardAP
2019-10-11Manufacturing (CMC) · Supplement 9 · unknownAP
2016-01-12Labeling · Supplement 3 · standardAP
2013-02-06Labeling · Supplement 2AP
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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