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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 AB 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
11/01/2021 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022301s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022301Orig1s018ltr.pdf
10/01/2020 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022301s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022301Orig1s015ltr.pdf
03/12/2019 SUPPL-14 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022301s014lbl.pdf
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
11/01/2021 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022301s018lbl.pdf
10/01/2020 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022301s015lbl.pdf
03/12/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022301s014lbl.pdf
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

APRISO

CAPSULE, EXTENDED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APRISO MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022301 VALEANT PHARMS INTL
MESALAMINE MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214242 ALKEM LABS LTD
MESALAMINE MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 207271 MYLAN
MESALAMINE MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209970 TEVA PHARMS USA
MESALAMINE MESALAMINE 375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208954 ZYDUS PHARMS
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