Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019010
Company: ABBVIE ENDOCRINE INC
Company: ABBVIE ENDOCRINE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUPRON | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |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 |