FDA.reportPublic FDA data

Application 201050

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0349Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0349Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52738ORIG2018-02-27
9857ORIG2012-07-18