Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020578
Company: TERSERA
Company: TERSERA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOLADEX | GOSERELIN ACETATE | EQ 10.8MG 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 |
|---|---|---|---|---|---|---|---|
| 01/11/1996 | 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 |
|---|---|---|---|---|---|
| 06/17/2021 | SUPPL-44 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020578Orig1s044ltr.pdf |
| 02/12/2015 | SUPPL-37 | 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-36 | 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-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf | |
| 06/18/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf | |
| 01/14/2011 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf | |
| 08/31/2009 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf | |
| 08/31/2009 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf | |
| 08/31/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf | |
| 10/19/2005 | SUPPL-25 | 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-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf |
| 02/28/2002 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf |
| 02/05/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20578s13ltr.pdf |
| 03/09/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-3 | 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 | |
| 06/09/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/1999 | 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 |
|---|---|---|---|---|---|
| 02/12/2015 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf | |
| 10/07/2014 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf | |
| 06/18/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf | |
| 06/18/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf | |
| 01/14/2011 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf | |
| 08/31/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf | |
| 08/31/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf | |
| 08/31/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf | |
| 07/27/1998 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf |