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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022372
Company: AZURITY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPREP BOWEL PREP KIT MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION;ORAL Prescription AA Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/18/2025 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022372s016lbl.pdf
11/18/2025 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022372s016lbl.pdf
08/05/2020 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022372Orig1s013lbl.pdf
11/06/2012 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
11/06/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
08/05/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf
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