APPLICATION
ANDA078915
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-06
LATEST ACTION
2022-11-02
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
2022-11-02Labeling · Supplement 6 · standardAP
2022-11-02Labeling · Supplement 2 · standardAP
2022-11-02Labeling · Supplement 9 · standardAP
2022-11-02Labeling · Supplement 7 · standardAP
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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