Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020578
Company: TERSERA THERAPS LLC
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English