Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019732
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON DEPOT LEUPROLIDE ACETATE 7.5MG/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
01/26/1989 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2019 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020517Orig1s042,019732Orig1s044ltr.pdf
12/10/2018 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019732s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019732Orig1s043, 020517Orig1s041ltr.pdf
06/06/2016 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf
06/27/2014 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf
07/10/2013 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf
02/17/2012 SUPPL-38 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019732s038ltr.pdf
01/14/2011 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf
04/28/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf
04/28/2010 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf
04/28/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf
09/15/2005 SUPPL-29 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/2005/019732_S029_Lupron Depot_APPROVAL PACKAGE.pdf
09/15/2005 SUPPL-27 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/2005/019732_S027_Lupron Depot_APPROVAL PACKAGE.pdf
01/12/2004 SUPPL-26 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-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf
05/23/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

03/01/2001 SUPPL-20 Labeling

Label is not available on this site.

01/24/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-16 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019732_S016_Lupron Depot_APPROVAL PACKAGE.pdf
10/04/1999 SUPPL-15 Labeling

Label is not available on this site.

06/30/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_PRNTLBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019732s012_lupron.cfm
08/11/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-9 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S009_Lupron Depot_APPROVAL PACKAGE.pdf
11/08/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1994 SUPPL-7 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S007_Lupron Depot_APPROVAL PACKAGE.pdf
04/26/1994 SUPPL-6 Labeling

Label is not available on this site.

03/26/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/14/1990 SUPPL-2 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
03/04/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf
12/10/2018 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019732s043lbl.pdf
06/06/2016 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf
06/27/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf
07/10/2013 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf
02/17/2012 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf
02/17/2012 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf
01/14/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf
04/28/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf
04/28/2010 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf
04/28/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf
01/09/1998 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_PRNTLBL.PDF

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