Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022301
Company: VALEANT PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APRISO MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;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
10/31/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022301s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301_apriso_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022301s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022301Orig1s009ltr.pdf
12/21/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/26/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/25/2013 SUPPL-4 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
07/27/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022301s009lbl.pdf
10/31/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf

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