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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203098
Company: PERRIGO ISRAEL

REMS

Summary Review

Products on NDA 203098

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Discontinued	None	No	No
TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Discontinued	None	No	No
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2013	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/2013/203098s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203098Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203098Orig1s009ltr.pdf
02/26/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/11/2015	SUPPL-6	Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203098Orig1s006ltr.pdf
02/03/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/19/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203098Orig1s002ltr.pdf
05/01/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203098

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf
05/11/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf
05/11/2015	SUPPL-6	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf
05/11/2015	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf
06/19/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf
01/31/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf

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