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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022058
Company: ENDO OPERATIONS

Medication Guide

Summary Review

Products on NDA 022058

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022058

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
09/23/2025	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022058s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022058Orig1s020ltr.pdf
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-Container/Carton Labels, 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
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

Labels for NDA 022058

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022058s020lbl.pdf
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-Container/Carton Labels	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-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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