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FDA ANDA · ANDA076491
TRILYTE
polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Sponsor: AUROBINDO PHARMA USA
APPLICATION
ANDA076491
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-05
LATEST ACTION
2020-12-21
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
TRILYTEPrescription
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
2020-12-21Labeling · Supplement 12 · standardAP
2008-10-08Labeling · Supplement 10AP
2004-08-26Labeling · Supplement 3AP
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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