FDA.reportPublic FDA data

Application 205811

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDETABLET, DELAYED RELEASE;ORAL10MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2132Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2132Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45104ORIG2016-08-23
45100ORIG2016-08-23