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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009165
Company: ENDO PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELATESTRYL TESTOSTERONE ENANTHATE 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
DELATESTRYL TESTOSTERONE ENANTHATE 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/24/1953 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

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/2016/009165s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009165Orig1s034ltr.pdf
05/11/2015 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009165s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009165Orig1s033ltr.pdf
06/19/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009165Orig1s032ltr.pdf
07/25/2007 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009165s031_ltr.pdf
03/07/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf
06/06/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
12/14/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
12/31/1997 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/09/1991 SUPPL-25 Labeling

Label is not available on this site.
05/05/1989 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/01/1987 SUPPL-22 Labeling

Label is not available on this site.
09/01/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
05/05/1986 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
07/31/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
01/31/1984 SUPPL-16 Labeling

Label is not available on this site.
02/01/1980 SUPPL-15 Efficacy

Label is not available on this site.
02/01/1980 SUPPL-14 Efficacy

Label is not available on this site.
08/02/1979 SUPPL-9 Efficacy

Label is not available on this site.
07/15/1977 SUPPL-6 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/2016/009165s034lbl.pdf
05/11/2015 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009165s033lbl.pdf
06/19/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf
07/25/2007 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s031lbl.pdf
03/07/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s030lbl.pdf
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