FDA.reportPublic FDA data

Application 008708

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIBENZYLINEPHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
66993-066Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-066Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20015SUPPL2012-02-28
40653SUPPL2011-10-10
32968SUPPL2008-04-16
103SUPPL2008-04-09
157SUPPL2004-06-02
158SUPPL2004-01-09