Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021830
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASACOL HD MESALAMINE 800MG TABLET, DELAYED 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
05/29/2008 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/2008/021830lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021830TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf
05/05/2016 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf
10/22/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/18/2013 SUPPL-6 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf
05/24/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf
04/23/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/27/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf
05/05/2016 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf
10/18/2013 SUPPL-6 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf
05/24/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf
04/23/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf
05/29/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf

ASACOL HD

TABLET, DELAYED RELEASE;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASACOL HD MESALAMINE 800MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 021830 APIL
MESALAMINE MESALAMINE 800MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203286 ZYDUS PHARMS USA INC

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