FDA.reportPublic FDA data

Application 021897

Type
NDA
Sponsor
ALKERMES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIVITROLNALTREXONEFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR380MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-300VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-301VIVITROLnaltrexoneAlkermes, Inc.NDACurrent
65757-301VIVITROLnaltrexoneAlkermes, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84687SUPPL 2026-01-06
84603SUPPL 2025-12-31
72224SUPPL2022-10-03
67444SUPPL2021-05-10
66597SUPPL2021-03-08
66596SUPPL2021-03-08
66553SUPPL2021-03-05
62896SUPPL2020-05-11
62884SUPPL2020-05-11
59948SUPPL2019-09-09
59947SUPPL2019-09-09
59938SUPPL2019-09-09
57102SUPPL2019-01-02
57056SUPPL2018-12-30
6412SUPPL2016-05-19
44485SUPPL2015-12-29
6411SUPPL2015-12-29
37844SUPPL2015-12-10
37843SUPPL2014-06-12
37842SUPPL2014-06-12
6410SUPPL2013-07-31
6409SUPPL2013-07-31
37841SUPPL2010-10-13
28806SUPPL2010-10-13
24012ORIG2010-10-13
16538SUPPL2010-03-26
16537SUPPL2010-03-26
6408SUPPL2010-03-25
6407SUPPL2010-03-25
44159ORIG2008-08-12
21863ORIG2008-01-16
28805SUPPL2007-11-08
16536SUPPL2007-11-07
6406ORIG2006-04-21
37840ORIG2006-04-14