Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021897
Company: ALKERMES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIVITROL NALTREXONE 380MG/VIAL FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 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
04/13/2006 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021897s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/09/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/20/2016 SUPPL-32 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021897Orig1s032ltr.pdf
05/19/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/19/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/08/2015 SUPPL-29 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021897Orig1s029Ltr.pdf
01/26/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/17/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/07/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/09/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/29/2013 SUPPL-23 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf
03/28/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/29/2013 SUPPL-20 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf
10/12/2010 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s015ltr.pdf
03/22/2010 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf
08/18/2010 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/22/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf
10/26/2007 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021897s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2015 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf
07/29/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf
07/29/2013 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf
07/29/2013 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf
07/29/2013 SUPPL-20 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf
10/12/2010 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf
03/22/2010 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf
03/22/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf
10/26/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf
04/13/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf

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