Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020263
Company: ABBVIE ENDOCRINE INC
Company: ABBVIE ENDOCRINE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 7.5MG | POWDER;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAMUSCULAR | Discontinued | None | Yes | No |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAMUSCULAR | Discontinued | None | Yes | No |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 11.25MG | POWDER;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 15MG | POWDER;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 11.25MG | POWDER;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 30MG | POWDER;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 45MG | POWDER;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1993 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2023 | SUPPL-54 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020263Orig1s054ltr.pdf | |
| 04/14/2023 | SUPPL-53 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020263Orig1s053ltr.pdf | |
| 04/22/2022 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020263s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020263Orig1s050ltr.pdf | |
| 11/12/2021 | SUPPL-48 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s048ltr.pdf |
| 03/11/2021 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s044,s047ltr.pdf | |
| 04/07/2020 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020263Orig1s046ltr.pdf | |
| 03/11/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s044,s047ltr.pdf | |
| 05/19/2017 | SUPPL-42 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020263Orig1s042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/020263Orig1s042.pdf | |
| 05/14/2013 | SUPPL-39 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf | |
| 10/08/2011 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf | |
| 08/15/2011 | SUPPL-36 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf | |
| 08/30/2010 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf | |
| 06/24/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf | |
| 07/31/2008 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf |
| 02/16/2006 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron Depot Ped_APPROVAL PACKAGE.pdf | |
| 11/09/2005 | SUPPL-26 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf | |
| 03/02/2004 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf | |
| 12/23/2003 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf |
| 10/28/2003 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf |
| 09/24/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf |
| 05/16/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/26/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron Depot_APPROVAL_PACKAGE.pdf |
| 06/30/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/11/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1995 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron Depot_APPROVAL PACKAGE.pdf |
| 03/24/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/07/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1994 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron Depot_APPROVAL PACKAGE.pdf |
| 01/21/1994 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 12/04/2023 | SUPPL-54 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263Orig1s054lbl.pdf | |
| 04/14/2023 | SUPPL-53 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263s053lbl.pdf | |
| 04/22/2022 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020263s050lbl.pdf | |
| 03/11/2021 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf | |
| 03/11/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf | |
| 03/11/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf | |
| 04/07/2020 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf | |
| 04/07/2020 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf | |
| 05/19/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf | |
| 05/19/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf | |
| 05/14/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf | |
| 05/14/2013 | SUPPL-39 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf | |
| 10/08/2011 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf | |
| 08/15/2011 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf | |
| 08/30/2010 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf | |
| 06/24/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf | |
| 02/16/2006 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf | |
| 11/09/2005 | SUPPL-26 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf |
| 03/02/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf |