Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019726
Company: TERSERA THERAPS LLC
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
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
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

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