Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204399
Company: UPSHER SMITH LABS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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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