Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022058
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
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
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

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