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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204399
Company: UPSHER SMITH LABS

Medication Guide

REMS

Summary Review

Products on NDA 204399

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOGELXO	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	AB2	No	No
VOGELXO	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204399Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204399Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000SumRedt.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204399Orig1s012ltr.pdf
05/30/2019	SUPPL-11	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204399Orig1s011ltr.pdf
05/10/2019	SUPPL-10	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204399s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204399Orig1s010ltr.pdf
10/25/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204399s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204399Orig1s004ltr.pdf
05/12/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/11/2015	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204399Orig1s002ltr.pdf

Labels for NDA 204399

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf
05/10/2019	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204399s010lbl.pdf
10/25/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204399s004lbl.pdf
05/11/2015	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf
05/11/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf
05/11/2015	SUPPL-2	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf
06/04/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204399s000lbl.pdf

Therapeutic Equivalents for NDA 204399

VOGELXO

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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