Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020263
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON DEPOT-PED LEUPROLIDE ACETATE 7.5MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT-PED LEUPROLIDE ACETATE 3.75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LUPRON DEPOT-PED LEUPROLIDE ACETATE 7.5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LUPRON DEPOT-PED LEUPROLIDE ACETATE 11.25MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT-PED LEUPROLIDE ACETATE 15MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT-PED LEUPROLIDE ACETATE 11.25MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT-PED LEUPROLIDE ACETATE 30MG/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
04/16/1993 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020263Orig1s042ltr.pdf
05/14/2013 SUPPL-39 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf
10/08/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf
08/15/2011 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf
08/30/2010 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf
06/24/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf
07/31/2008 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf
02/16/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron Depot Ped_APPROVAL PACKAGE.pdf
11/09/2005 SUPPL-26 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf
03/02/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf
12/23/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf
10/28/2003 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf
09/24/2002 SUPPL-20 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf
05/16/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/2001 SUPPL-17 Labeling

Label is not available on this site.

01/26/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron Depot_APPROVAL_PACKAGE.pdf
06/30/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1997 SUPPL-9 Labeling

Label is not available on this site.

08/11/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-6 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron Depot_APPROVAL PACKAGE.pdf
03/24/1995 SUPPL-5 Labeling

Label is not available on this site.

11/07/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1994 SUPPL-3 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron Depot_APPROVAL PACKAGE.pdf
01/21/1994 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
05/19/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf
05/19/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf
05/14/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf
05/14/2013 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf
10/08/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf
08/15/2011 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf
08/30/2010 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf
06/24/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf
02/16/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf
11/09/2005 SUPPL-26 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf
03/02/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf

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