Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022058
Company: ENDO PHARM
Company: ENDO PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUPPRELIN LA | HISTRELIN ACETATE | 50MG | IMPLANT;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
05/03/2007 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058_supprelin_la_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/22/2022 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022058s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022058Orig1s017ltr.pdf | |
11/08/2019 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022058s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022058Orig1s016ltr.pdf | |
05/19/2017 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022058Orig1s014s015ltr.pdf | |
05/19/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022058Orig1s014s015ltr.pdf | |
04/21/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022058Orig1s011ltr.pdf | |
04/05/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022058s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022058s009ltr.pdf | |
06/19/2013 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s008lbl.pdf | |
10/30/2011 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022058s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022058s006ltr.pdf | |
07/02/2008 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022058s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022058s003ltr.pdf | |
11/21/2007 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/22/2022 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022058s017lbl.pdf | |
04/22/2022 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022058s017lbl.pdf | |
11/08/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022058s016lbl.pdf | |
05/19/2017 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf | |
05/19/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf | |
05/19/2017 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf | |
05/19/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf | |
06/19/2013 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s008lbl.pdf |
04/02/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf | |
04/05/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022058s009lbl.pdf | |
10/30/2011 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022058s006lbl.pdf | |
07/02/2008 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022058s003lbl.pdf | |
05/03/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022058lbl.pdf |