Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020517
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON DEPOT LEUPROLIDE ACETATE 22.5MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT LEUPROLIDE ACETATE 30MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
LUPRON DEPOT LEUPROLIDE ACETATE 45MG/VIAL INJECTABLE;INJECTION Prescription None Yes 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
12/22/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020517_S000_Lupron_Depot.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/06/2016 SUPPL-38 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
02/11/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/27/2014 SUPPL-36 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-35 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
11/08/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/18/2012 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020517Origs033ltr.pdf
06/17/2011 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf
01/14/2011 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf
06/17/2011 SUPPL-30 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf
04/28/2010 SUPPL-29 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-28 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
06/17/2011 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf
04/28/2010 SUPPL-24 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-19 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/2005/020517_S019_Lupron Depot_APPROVAL PACKAGE.pdf
09/15/2005 SUPPL-18 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/2005/020517_S018_Lupron Depot_APPROVAL PACKAGE.pdf
01/12/2004 SUPPL-16 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-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/2003 SUPPL-13 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-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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/99/020517_S006_Lupron Depot_APPROVAL PACKAGE.pdf
07/29/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1997 SUPPL-2 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020517_s002ap.pdf
12/03/1996 SUPPL-1 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20517S001_Lupron.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf
06/27/2014 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf
07/10/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf
07/18/2012 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf
06/17/2011 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf
06/17/2011 SUPPL-30 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf
06/17/2011 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf
01/14/2011 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf
04/28/2010 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf
04/28/2010 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf
04/28/2010 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf

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