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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021454
Company: AUXILIUM PHARMS LLC

Medication Guide

REMS

Products on NDA 021454

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTIM	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	AB2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21454ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-454_Testim.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2021	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021454s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021454Orig1s034ltr.pdf
11/30/2020	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021454Orig1s030, s031ltr.pdf
11/30/2020	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021454Orig1s030, s031ltr.pdf
05/30/2019	SUPPL-29	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021454Orig1s029ltr.pdf
05/10/2019	SUPPL-27	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021454Orig1s027ltr.pdf
08/20/2021	SUPPL-25		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021454s034lbl.pdf
10/25/2016	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021454s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021454Orig1s024ltr.pdf
05/11/2015	SUPPL-23	Labeling-Package Insert, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021454Orig1s023ltr.pdf
04/09/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/19/2014	SUPPL-21	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s021ltr.pdf
05/01/2014	SUPPL-20	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s020ltr.pdf
01/02/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/30/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021454Orig1s016ltr.pdf
11/22/2011	SUPPL-14	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021454s014ltr.pdf
09/18/2009	SUPPL-8	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021454s008ltr.pdf

Labels for NDA 021454

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2021	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021454s034lbl.pdf
08/20/2021	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021454s034lbl.pdf
11/30/2020	SUPPL-31	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf
11/30/2020	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf
11/30/2020	SUPPL-30	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf
11/30/2020	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf
05/10/2019	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf
05/10/2019	SUPPL-27	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf
10/25/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021454s024lbl.pdf
05/11/2015	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf
05/11/2015	SUPPL-23	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf
06/19/2014	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf
08/30/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf
11/22/2011	SUPPL-14	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf
09/18/2009	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf
09/18/2009	SUPPL-8	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf
10/31/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf

Therapeutic Equivalents for NDA 021454

TESTIM

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTIM	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	Yes	AB2	021454	AUXILIUM PHARMS LLC
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB2	091073	ACTAVIS LABS UT INC
VOGELXO	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB2	204399	UPSHER SMITH LABS

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