APPLICATION
ANDA203928
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-24
LATEST ACTION
2023-02-08
ROUTE
ORAL, TOPICAL
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
2023-02-08Labeling · Supplement 5 · standardAP
2023-02-08Labeling · Supplement 11 · standardAP
2016-08-24UNKNOWN · OriginalAP
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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