Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022372
Company: BRAINTREE LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/05/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022372s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372_suprep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/24/2012 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/06/2012 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022372Orig1s004ltr.pdf
07/06/2011 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022372s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
11/06/2012 SUPPL-4 Labeling-Container/Carton Labels 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

SUPREP BOWEL PREP KIT

SOLUTION;ORAL; 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION;ORAL Prescription No AA 202511 NOVEL LABS INC
SUPREP BOWEL PREP KIT MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION;ORAL Prescription Yes AA 022372 BRAINTREE LABS

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