Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019943
Company: ABBOTT LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON LEUPROLIDE ACETATE 3.75MG INJECTABLE; INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1995 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_LupronTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2013 SUPPL-34 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.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/2012/019943s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf
06/14/2011 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf
03/28/2012 SUPPL-31 Labeling-Package Insert 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-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf
06/02/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.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-24 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/2005/019943_S024_Lupron Depot_APPROVAL PACKAGE.pdf
09/15/2005 SUPPL-22 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/2005/019943_S022_Lupron Depot_APPROVAL PACKAGE.pdf
01/12/2004 SUPPL-21 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-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2004 SUPPL-18 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-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2001 SUPPL-15 Labeling

Label is not available on this site.

03/01/2001 SUPPL-14 Labeling

Label is not available on this site.

01/24/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

08/13/1999 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019943_S010_Lupron Depot_APPROVAL PACKAGE.pdf
06/30/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1996 SUPPL-6 Labeling

Label is not available on this site.

08/11/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1995 SUPPL-3 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_S003_Lupron Depot_APPROVAL PACKAGE.pdf
12/12/1995 SUPPL-2 Labeling

Label is not available on this site.

09/22/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2013 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.pdf
03/28/2012 SUPPL-31 Labeling-Package Insert 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/2012/019943s033lbl.pdf
06/14/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf
10/29/2010 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf
06/02/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf

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