Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019010
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE;INJECTION Discontinued 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
04/09/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2018 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019010s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019010Orig1s041ltr.pdf
07/11/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s039ltr.pdf
05/19/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/019010Orig1s038.pdf
07/10/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019010Orig1s037ltr.pdf
01/14/2011 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/019010s036,019732s037,020517Orig1s031ltr_C.pdf
03/21/2011 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s035ltr.pdf
04/28/2010 SUPPL-33 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
09/14/2007 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019010s032ltr.pdf
09/15/2005 SUPPL-31 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/2005/019010_S031_Lupron Injection_APPROVAL_PACKAGE.pdf
10/18/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19010s028ltr.pdf
11/25/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19010slr027ltr.pdf
05/16/2002 SUPPL-24 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S024_Lupron Injection_APPROVAL_PACKAGE.pdf
05/16/2002 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S023_Lupron Injection_APPROVAL_PACKAGE.pdf
12/21/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/09/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1988 SUPPL-6 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010_S006_Lupron Injection_APPROVAL PACKAGE.pdf
01/14/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1987 SUPPL-4 Labeling

Label is not available on this site.

01/19/1988 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1986 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
12/10/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019010s041lbl.pdf
07/11/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s039lbl.pdf
05/19/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf
07/10/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf
03/21/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf
01/14/2011 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf
04/28/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf

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