Acebutolol Oral Capsule

Brand(s)
Sectral
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Reddy Pharmaceuticals, Llc (2012-01-12)
Oldest Current Product
1984-12-28
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\ACEBUTOLOL
FDAOB
ORAL\CAPSULE\ACEBUTOLOL HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\ACEBUTOLOL HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\ACEBUTOLOL

product(s) by strength(s)

acebutolol hydrochloride 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1678570700SectralNDAReddy Pharmaceuticals, Llc1984-12-28ACEBUTOLOL HYDROCHLORIDEORALCAPSULENDA0189177eee95bf-0452-4d6e-9712-33403768695a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781200ANDAMylan Pharmaceuticals Inc.1995-04-24ACEBUTOLOL HYDROCHLORIDEORALCAPSULEANDA0742886bfb00a0-c057-4dfb-9ae3-e5b7d782cd24
2651620669ANDAAmneal Pharmaceuticals2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULEANDA07504728f8c26c-a1e1-4485-a45f-05c82f7a34b5

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046173ANDAMajor2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620669ANDA075047b13ea512-c15c-4f5e-beff-8d4e95917999
2422910101ANDAAvkare, Inc.2009-12-14ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620669ANDA075047cee9d238-be0f-f1ed-0002-2e990075fda4
3502680050ANDAAvpak2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620669ANDA075047ff68a002-d46d-4f9f-0705-427844ea3655
4548685520ANDAPhysicians Total Care, Inc.2006-02-012012-06-30ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620669ANDA075047201b752c-64b4-4687-acc1-3a92bfda864e
5636293871ANDABryant Ranch Prepack2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620669ANDA0750478747d9c1-2854-44af-892a-38433b2ed4cc

acebutolol hydrochloride 400 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1678570701SectralNDAReddy Pharmaceuticals, Llc1984-12-28ACEBUTOLOL HYDROCHLORIDEORALCAPSULENDA0189177eee95bf-0452-4d6e-9712-33403768695a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781400ANDAMylan Pharmaceuticals Inc.1995-04-24ACEBUTOLOL HYDROCHLORIDEORALCAPSULEANDA0742886bfb00a0-c057-4dfb-9ae3-e5b7d782cd24
2651620670ANDAAmneal Pharmaceuticals2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULEANDA07504728f8c26c-a1e1-4485-a45f-05c82f7a34b5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910102ANDAAvkare, Inc.2009-12-14ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620670ANDA075047cee9d238-be0f-f1ed-0002-2e990075fda4
2502680051ANDAAvpak2009-12-01ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620670ANDA075047ff68a002-d46d-4f9f-0705-427844ea3655
3548684216ANDAPhysicians Total Care, Inc.2005-04-22ACEBUTOLOL HYDROCHLORIDEORALCAPSULE651620670ANDA075047201b752c-64b4-4687-acc1-3a92bfda864e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074007ACEBUTOLOL HYDROCHLORIDETrueWATSON LABORATORIES INC1995-10-18ANDA074007_001, ANDA074007_002
2ANDA074288ACEBUTOLOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1995-04-24ANDA074288_001, ANDA074288_002
3ANDA075047ACEBUTOLOL HYDROCHLORIDEAMNEAL PHARMACEUTICAL1999-12-30ANDA075047_001, ANDA075047_002
4NDA018917SECTRALPROMIUS PHARMA LLC1984-12-28NDA018917_001, NDA018917_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074007_001discontinuedACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE)ORALCAPSULEFalse1995-10-18ACEBUTOLOL HYDROCHLORIDE
2ANDA074007_002discontinuedACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE)ORALCAPSULEFalse1995-10-18ACEBUTOLOL HYDROCHLORIDE
3ANDA074288_001RXACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE)ORALCAPSULEFalseAB1995-04-24ACEBUTOLOL HYDROCHLORIDE
4ANDA074288_002RXACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE)ORALCAPSULEFalseAB1995-04-24ACEBUTOLOL HYDROCHLORIDE
5ANDA075047_001RXACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE)ORALCAPSULEFalseAB1999-12-30ACEBUTOLOL HYDROCHLORIDE
6ANDA075047_002RXACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE)ORALCAPSULEFalseAB1999-12-30ACEBUTOLOL HYDROCHLORIDE
7NDA018917_001RXACEBUTOLOL HYDROCHLORIDE (EQ 200MG BASE)ORALCAPSULEFalseAB1984-12-28SECTRAL
8NDA018917_003RXACEBUTOLOL HYDROCHLORIDE (EQ 400MG BASE)ORALCAPSULETrueAB1984-12-28SECTRAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1201b752c-64b4-4687-acc1-3a92bfda864e (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-243548684216, 548685520
228f8c26c-a1e1-4485-a45f-05c82f7a34b5 (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-03-026651620669, 651620670
36bfb00a0-c057-4dfb-9ae3-e5b7d782cd24 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-09-197003781200, 003781400
47eee95bf-0452-4d6e-9712-33403768695a (view SPL)prescriptionHuman PrescriptionReddy Pharmaceuticals, Llcmanufacture2012-01-121678570700, 678570701
58747d9c1-2854-44af-892a-38433b2ed4cc (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-04-281000636293871
6b13ea512-c15c-4f5e-beff-8d4e95917999 (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionMajorRELABEL, REPACK2011-04-074009046173
7cee9d238-be0f-f1ed-0002-2e990075fda4 (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionAvkare, Inc.2015-07-318422910101, 422910102
8ff68a002-d46d-4f9f-0705-427844ea3655 (view SPL)ACEBUTOLOL HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionAvpak2014-09-025502680050, 502680051

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