FDA.reportPublic FDA data

Application 021964

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RELISTORMETHYLNALTREXONE BROMIDESOLUTION;SUBCUTANEOUS12MG/0.6ML (12MG/0.6ML)YesYes
002RELISTORMETHYLNALTREXONE BROMIDESOLUTION;SUBCUTANEOUS8MG/0.4ML (8MG/0.4ML)YesYes
003RELISTORMETHYLNALTREXONE BROMIDESOLUTION;SUBCUTANEOUS12MG/0.6ML (12MG/0.6ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-551RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent
65649-552RelistorMethylnaltrexone bromideSalix Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66357SUPPL2021-02-24
52979SUPPL2018-03-15
52966SUPPL2018-03-15
49562SUPPL2017-08-29
49222SUPPL2017-08-03
49219SUPPL2017-08-03
48459SUPPL2017-05-19
48437SUPPL2017-05-18
28932SUPPL2014-10-02
16648SUPPL2014-09-30
28933SUPPL2013-08-27
16649SUPPL2013-08-27
16647SUPPL2010-07-30
28931SUPPL2010-07-28
6548SUPPL2010-01-21
16646SUPPL2009-11-23
42362ORIG2008-06-03
28930ORIG2008-04-28