Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021732
Company: ENDO PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANTAS 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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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