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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021463
Company: ENDO PHARMS

Medication Guide

REMS

Summary Review

Products on NDA 021463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FORTESTA	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED;TRANSDERMAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2010	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/2010/021463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021463s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2020	SUPPL-25	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021463Orig1s025ltr.pdf
03/13/2020	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021463Orig1s022ltr.pdf
05/30/2019	SUPPL-21	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021463Orig1s021ltr.pdf
05/10/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021463Orig1s020ltr.pdf
10/25/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021463Orig1s019ltr.pdf
03/10/2016	SUPPL-18	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s018lbl.pdf
05/11/2015	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021463Orig1s017ltr.pdf
07/31/2014	SUPPL-15	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s015ltr.pdf
06/19/2014	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s014ltr.pdf
06/04/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/24/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s012ltr.pdf
11/26/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/11/2013	SUPPL-10	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021463Orig1s010ltr.pdf
09/09/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021463

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2020	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf
03/13/2020	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s022lbl.pdf
05/10/2019	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf
05/10/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf
10/25/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s019lbl.pdf
03/10/2016	SUPPL-18	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s018lbl.pdf
05/11/2015	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
05/11/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
05/11/2015	SUPPL-17	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
06/19/2014	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf
06/19/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf
03/24/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf
09/11/2013	SUPPL-10	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf
12/29/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021463s000lbl.pdf

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