← FDA DRUG APPROVALS

FDA ANDA · ANDA090145

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Sponsor: NOVEL LABS INC

APPLICATION
ANDA090145
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-25
LATEST ACTION
2019-12-17
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDPrescription
ASCORBIC ACID 4.7GM, POLYETHYLENE GLYCOL 3350 100GM, POTASSIUM CHLORIDE 1.015GM, SODIUM ASCORBATE 5.9GM, SODIUM CHLORIDE 2.691GM, SODIUM SULFATE 7.5GM · FOR SOLUTION · ORAL

Approval history

2019-12-17Labeling · Supplement 4 · standardAP
2012-06-13Labeling · Supplement 1AP
2012-01-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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