Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202535
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREPOPIK CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 12GM/PACKET;3.5GM/PACKET;10MG/PACKET FOR SOLUTION;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202535Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535_prepopik_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/15/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202535Orig1s005ltr.pdf
05/06/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/21/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/13/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/15/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf
07/16/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf

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