Drugs@FDA: FDA Approved Drug Products

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

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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