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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204768
Company: GENUS

Medication Guide

Summary Review

Products on NDA 204768

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIVORBEX	INDOMETHACIN	20MG	CAPSULE;ORAL	Discontinued	None	Yes	No
TIVORBEX	INDOMETHACIN	40MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2014	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/2014/204768s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204768Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204768s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204768Orig1s008ltr.pdf
03/26/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204768s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204768Orig1s006ltr.pdf
05/09/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf
05/09/2016	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf
07/15/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204768

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204768s008lbl.pdf
04/28/2021	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204768s008lbl.pdf
03/26/2019	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204768s006lbl.pdf
03/26/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204768s006lbl.pdf
05/09/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
05/09/2016	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
05/09/2016	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
05/09/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf
02/24/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204768s000lbl.pdf

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