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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215344
Company: BRAINTREE LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUFLAVE MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/2023 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215344s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215344Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215344Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/15/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215344s000lbl.pdf
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