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New Drug Application (NDA): 204516
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRISDELLE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;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
06/28/2013 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/2013/204516s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204516Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2021 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204516s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204516Orig1s011ltr.pdf
04/28/2017 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s005ltr.pdf
01/04/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s004ltr.pdf
12/01/2014 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204516Orig1s003ltr.pdf
04/01/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 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
09/20/2021 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204516s011lbl.pdf
04/28/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf
04/28/2017 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf
01/04/2017 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s004lbl.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s004lbl.pdf
12/01/2014 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf
12/01/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf
06/28/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204516s000lbl.pdf

BRISDELLE

CAPSULE;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRISDELLE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription Yes AB 204516 SEBELA IRELAND LTD
PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription No AB 207139 ACTAVIS LABS FL INC
PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription No AB 207188 PRINSTON INC
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