Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020708
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON DEPOT LEUPROLIDE ACETATE 11.25MG/VIAL INJECTABLE;INJECTION 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
03/07/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020708_lupron_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2020 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020708s038lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020708Orig1s038ltr.pdf
04/18/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020708Orig1s035ltr.pdf
10/30/2013 SUPPL-34 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf
01/23/2012 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020708s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf
06/14/2011 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf
03/28/2012 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf
10/29/2010 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf
06/02/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.pdf
10/31/2007 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf
09/15/2005 SUPPL-21 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S021_Lupron Depot_APPROVAL PACKAGE.pdf
09/15/2005 SUPPL-20 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S020_Lupron Depot_APPROVAL PACKAGE.pdf
01/12/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf
09/20/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2004 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf
05/23/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2001 SUPPL-13 Labeling

Label is not available on this site.

07/23/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron.cfm
03/01/2001 SUPPL-10 Labeling

Label is not available on this site.

01/24/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020708_S006_Lupron Depot_APPROVAL PACKAGE.pdf
02/11/1999 SUPPL-5 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5.cfm
07/29/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1998 SUPPL-3 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm
12/23/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1997 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
03/18/2020 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020708s038lblrpl.pdf
04/18/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf
10/30/2013 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf
03/28/2012 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf
01/23/2012 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020708s033lbl.pdf
06/14/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf
10/29/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf
06/02/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf
09/21/2001 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf

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