Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020708
Company: ABBVIE ENDOCRINE INC
Company: ABBVIE ENDOCRINE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | LEUPROLIDE ACETATE | 11.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020708_lupron_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2020 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020708s038lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020708Orig1s038ltr.pdf | |
| 04/18/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020708Orig1s035ltr.pdf | |
| 10/30/2013 | SUPPL-34 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.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/2012/020708s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf | |
| 06/14/2011 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf | |
| 03/28/2012 | SUPPL-31 | Labeling |
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 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf | |
| 06/02/2009 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.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-21 | 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/2005/020708_S021_Lupron Depot_APPROVAL PACKAGE.pdf |
| 09/15/2005 | SUPPL-20 | 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/2005/020708_S020_Lupron Depot_APPROVAL PACKAGE.pdf |
| 01/12/2004 | SUPPL-18 | 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-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/2004 | SUPPL-15 | 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-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron.cfm | |
| 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/99/020708_S006_Lupron Depot_APPROVAL PACKAGE.pdf |
| 02/11/1999 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5.cfm |
| 07/29/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1998 | SUPPL-3 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm |
| 12/23/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2020 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020708s038lblrpl.pdf | |
| 04/18/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf | |
| 10/30/2013 | SUPPL-34 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf | |
| 03/28/2012 | SUPPL-31 | Labeling | 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/2012/020708s033lbl.pdf | |
| 06/14/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf | |
| 10/29/2010 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf | |
| 06/02/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf | |
| 09/21/2001 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf |