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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022309
Company: BESINS HLTHCARE

Medication Guide

Summary Review

Products on NDA 022309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	AB	Yes	Yes
ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued	None	Yes	No
ANDROGEL	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2011	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/2011/022309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309_androgel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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/2019/022309Orig1s021ltr.pdf
05/10/2019	SUPPL-20	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022309Orig1s020ltr.pdf
02/25/2019	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022309Orig1s018ltr.pdf
10/25/2016	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022309Orig1s017ltr.pdf
08/17/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/11/2015	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022309Orig1s014ltr.pdf
06/11/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/19/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf
11/14/2014	SUPPL-11	Labeling-Package Insert, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf
02/28/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/20/2013	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s008ltr.pdf
03/12/2013	SUPPL-7	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s007ltr.pdf
03/13/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/19/2012	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/07/2012	SUPPL-1	Labeling-Container/Carton Labels, REMS-Modified	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022309Orig1s001.pdf

Labels for NDA 022309

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2019	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf
02/25/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s008lbl.pdf
10/25/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf
05/11/2015	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
05/11/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
05/11/2015	SUPPL-14	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
11/14/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf
11/14/2014	SUPPL-11	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf
06/19/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf
05/20/2013	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf
05/20/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf
09/07/2012	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf
09/07/2012	SUPPL-1	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf
04/29/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf

Therapeutic Equivalents for NDA 022309

ANDROGEL

GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	Yes	AB	022309	BESINS HLTHCARE
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	204570	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	207373	AMNEAL
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	208620	ENCUBE
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	208560	LUPIN
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	204268	PADAGIS ISRAEL
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	209390	TWI PHARMS
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	210835	XIROMED

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