← FDA DRUG APPROVALS

FDA NDA · NDA022372

SUPREP BOWEL PREP

sodium sulfate, potassium sulfate, magnesium sulfate

Sponsor: AZURITY

APPLICATION
NDA022372
TYPE
NDA
ORIGINAL APPROVAL
2010-08-05
LATEST ACTION
2025-11-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SUPREP BOWEL PREP KIT · ReferencePrescription
MAGNESIUM SULFATE 1.6GM/BOT, POTASSIUM SULFATE 3.13GM/BOT, SODIUM SULFATE 17.5GM/BOT · SOLUTION · ORAL

Approval history

2025-11-18Labeling · Supplement 16 · standard — Letter ↗AP
2020-08-05Efficacy · Supplement 13 · standard — Label ↗AP
2012-11-06Labeling · Supplement 4 · standard — Label ↗AP
2012-07-24Manufacturing (CMC) · Supplement 6 · standardAP
2011-07-06REMS · Supplement 3 — Letter ↗AP
2010-08-05Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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