Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020489
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANDRODERM TESTOSTERONE 2.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ANDRODERM TESTOSTERONE 5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ANDRODERM TESTOSTERONE 2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes Yes
ANDRODERM TESTOSTERONE 4MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020489s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020489Orig1s034ltr.pdf
05/11/2015 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020489Orig1s033ltr.pdf
04/30/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/19/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020489Orig1s031ltr.pdf
01/16/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/26/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020489Orig1s027ltr.pdf
10/20/2011 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020489s025ltr.pdf
05/19/2006 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020489s013LTR.pdf
11/27/2002 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/09/2002 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489slr010ltr.pdf
10/24/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2002 SUPPL-7 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489s7ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020489_S007_ANDRODERM_AP.pdf
10/09/1998 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/29/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1998 SUPPL-4 Labeling

Label is not available on this site.

05/02/1997 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20489-S003_ANDRODERM.PDF
04/22/1997 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/10/1996 SUPPL-1 Labeling

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-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020489s034lbl.pdf
05/11/2015 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf
06/19/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf
04/26/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf
10/20/2011 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf
05/19/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf

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