Phenoxybenzamine Oral Capsule

Brand(s)
Dibenzyline
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Concordia Pharmaceuticals Inc. (2015-07-31)
Oldest Current Product
1953-01-26
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\PHENOXYBENZAMINE
FDAOB
ORAL\CAPSULE\PHENOXYBENZAMINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\PHENOXYBENZAMINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\PHENOXYBENZAMINE

product(s) by strength(s)

phenoxybenzamine hydrochloride 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1592120001DibenzylineNDAConcordia Pharmaceuticals Inc.1953-01-26PHENOXYBENZAMINE HYDROCHLORIDEORALCAPSULENDA0087088852dd44-098c-4d99-88e0-a092a8e08e11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540349ANDARoxane Laboratories, Inc2015-08-10PHENOXYBENZAMINE HYDROCHLORIDEORALCAPSULEANDA20105079a53bb1-fa5a-41a7-aeaf-01a60fb4f810
2669930066NDA AUTHORIZED GENERICPrasco Laboratories2015-08-11PHENOXYBENZAMINE HYDROCHLORIDEORALCAPSULENDA00870829ddb739-0f8e-4c41-ab4b-a6331ae2d508

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201050PHENOXYBENZAMINE HYDROCHLORIDEROXANE LABORATORIES INC2012-07-16ANDA201050_001
2NDA008708DIBENZYLINECONCORDIA PHARMACEUTICALS INCNDA008708_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201050_001RXPHENOXYBENZAMINE HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2012-07-16PHENOXYBENZAMINE HYDROCHLORIDE
2NDA008708_001RXPHENOXYBENZAMINE HYDROCHLORIDE (10MG)ORALCAPSULETrueABDIBENZYLINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
129ddb739-0f8e-4c41-ab4b-a6331ae2d508 (view SPL)Rx OnlyPrescribing InformationPhenoxybenzamine hydrochloride capsules, USP10 mgadrenergic, alpha-receptor-blocking agentprescriptionHuman PrescriptionPrasco Laboratories2015-08-1110669930066
24fcdf9ca-78a8-4e4b-958e-2f795bbbf9ca (view SPL)Dibenzyline (phenoxybenzamine hydrochloride, USP) Capsules 10 mgadrenergic, alpha-receptor-blocking agentprescriptionHuman PrescriptionWellspring Pharmaceutical CorporationANALYSIS, LABEL, MANUFACTURE, PACK2009-03-0121651970001
379a53bb1-fa5a-41a7-aeaf-01a60fb4f810 (view SPL)PHENOXYBENZAMINE HYDROCHLORIDE Capsules USPprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-08-101000540349
48852dd44-098c-4d99-88e0-a092a8e08e11 (view SPL)Dibenzyline (phenoxybenzamine hydrochloride capsules, USP) 10 mgadrenergic, alpha-receptor-blocking agentprescriptionHuman PrescriptionConcordia Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-311592120001

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII