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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021732
Company: ENDO OPERATIONS

Products on NDA 021732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANTAS	HISTRELIN ACETATE	50MG	IMPLANT;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21732lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21732ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021732s000_VantasTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2022	SUPPL-24	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021732Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021732Orig1s024ltr.pdf
12/16/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021732s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021732Orig1s023ltr.pdf
02/11/2019	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021732s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021732Orig1s022ltr.pdf
07/31/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/08/2014	SUPPL-19	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021732Orig1s019ltr.pdf
04/04/2013	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021732s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021732Orig1s018ltr.pdf
01/09/2014	SUPPL-15	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021732s015lbl.pdf
01/14/2011	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s013ltr.pdf
02/04/2011	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf
02/04/2011	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf
02/04/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf
09/25/2008	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021732

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021732Orig1s024lbl.pdf
08/23/2022	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021732Orig1s024lbl.pdf
12/16/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021732s023lbl.pdf
02/11/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021732s022lbl.pdf
02/11/2019	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021732s022lbl.pdf
01/09/2014	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021732s015lbl.pdf
04/04/2013	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021732s018lbl.pdf
02/04/2011	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf
02/04/2011	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf
02/04/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf
01/14/2011	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s013lbl.pdf
10/12/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21732lbl.pdf

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