Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204412
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELZICOL MESALAMINE 400MG CAPSULE, 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
02/01/2013 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204412Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204412_delzicol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204412s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf
09/09/2015 SUPPL-6 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204412Orig1s006ltr.pdf
12/02/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/27/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s004ltr.pdf
04/28/2014 SUPPL-3 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s003ltr.pdf
10/22/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/09/2013 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
07/27/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204412s008lbl.pdf
09/09/2015 SUPPL-6 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf
10/27/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf
04/28/2014 SUPPL-3 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf
02/01/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf

DELZICOL

CAPSULE, DELAYED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELZICOL MESALAMINE 400MG CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 204412 APIL
MESALAMINE MESALAMINE 400MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 207873 TEVA PHARMS USA

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