Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019726
Company: TERSERA
Company: TERSERA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOLADEX | GOSERELIN ACETATE | EQ 3.6MG BASE | IMPLANT;IMPLANTATION | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 03/16/2023 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019726s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019726Orig1s069ltr.pdf | |
| 06/17/2021 | SUPPL-66 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019726Orig1s066ltr.pdf |
| 07/19/2016 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2015 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf | |
| 10/07/2014 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf | |
| 06/18/2013 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf | |
| 06/18/2013 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf | |
| 01/14/2011 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf | |
| 08/31/2009 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf | |
| 08/31/2009 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf | |
| 08/31/2009 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf | |
| 05/07/2008 | SUPPL-49 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2005 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf |
| 06/24/2004 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf |
| 09/13/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf |
| 01/29/2002 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-34 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s34ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf |
| 10/16/2000 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/20/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.cfm | |
| 11/13/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1998 | SUPPL-22 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf |
| 08/20/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-18 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19726S018_Zoladex.cfm |
| 12/18/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/14/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/28/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/15/1991 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/17/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/16/2023 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019726s069lbl.pdf | |
| 02/12/2015 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf | |
| 10/07/2014 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf | |
| 06/18/2013 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf | |
| 06/18/2013 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf | |
| 01/14/2011 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf | |
| 08/31/2009 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf | |
| 08/31/2009 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf | |
| 08/31/2009 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf | |
| 07/27/1998 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf |