Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020517
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 | 22.5MG | INJECTABLE;INJECTION | Prescription | None | Yes | No |
| LUPRON DEPOT | LEUPROLIDE ACETATE | 30MG | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| LUPRON DEPOT | LEUPROLIDE ACETATE | 45MG | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 03/21/2024 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019732s049,020517s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019732Orig1s049ltr, 020517Orig1s046ltr.pdf | |
| 12/04/2023 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020517s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019732Orig1s048; 020517Orig1s045ltr.pdf | |
| 04/18/2022 | SUPPL-43 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019732s045,020517s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019732Orig1s045; 020517Orig1s043Corrected_ltr.pdf | |
| 03/04/2019 | SUPPL-42 | 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-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020517s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019732Orig1s043,%20020517Orig1s041ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/21/2024 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019732s049,020517s046lbl.pdf | |
| 12/04/2023 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020517s045lbl.pdf | |
| 04/18/2022 | SUPPL-43 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019732s045,020517s043lbl.pdf | |
| 03/04/2019 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf | |
| 12/10/2018 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020517s041lbl.pdf | |
| 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 |