Drugs@FDA: FDA-Approved Drugs
Company: ENDO PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DELATESTRYL | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
DELATESTRYL | TESTOSTERONE ENANTHATE | 200MG/ML | 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 |