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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204516
Company: SEBELA IRELAND LTD

Medication Guide

Summary Review

Products on NDA 204516

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204516

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
08/18/2023	SUPPL-13	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204516s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204516Orig1s013ltr.pdf
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-Medication Guide, Labeling-Package Insert	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.

Labels for NDA 204516

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204516s013lbl.pdf
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf
04/28/2017	SUPPL-5	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 204516

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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